I

107TH CONGRESS

1ST SESSION H. R. 2180

To amend the Federal Food, Drug, and Cosmetic Act to grant the Secretary

of Health and Human Services the authority to regulate tobacco products, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JUNE 14, 2001

Mr. TOM DAVIS of Virginia (for himself, Mr. GILLMOR, Mr. GREEN of Wisconsin, Mr. SWEENEY, Ms. GRANGER, Mr. TOWNS, Mr. LINDER, Mr.

FERGUSON, Mr. COLLINS, Mr. SCHROCK, Mrs. BONO, Mr. PETERSON of

Minnesota, Mr. GRUCCI, Mr. TERRY, and Mr. DOYLE) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

grant the Secretary of Health and Human Services the

authority to regulate tobacco products, and for other

purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘National Youth Smok5 ing Reduction Act’’.
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1 SEC. 2. FINDINGS.

2 The Congress finds the following:

3 (1) The use of tobacco products by the Nation’s

4 children is a pediatric disease of epic proportions

5 that results in new generations of tobacco-dependent

6 children and adults.

7 (2) A consensus exists within the scientific and

8 medical communities that tobacco products are in9 herently dangerous and cause cancer, heart disease,

10 and other serious adverse health effects.

11 (3) Nicotine is addictive.

12 (4) Virtually all new users of tobacco products

13 are under the minimum legal age to purchase such

14 products.

15 (5) Tobacco advertising and marketing con16 tribute significantly to the use of nicotine-containing

17 tobacco products by adolescents.

18 (6) Because past efforts to restrict advertising

19 and marketing of tobacco products have failed ade20 quately to curb tobacco use by adolescents, com21 prehensive restrictions on the sale, promotion, and

22 distribution of such products are needed.

23 (7) Federal and State governments have lacked

24 the legal and regulatory authority and resources

25 they need to address comprehensively the public
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1 health and societal problems caused by the use of to2 bacco products.

3 (8) Federal and State public health officials,

4 the public health community, and the public at large

5 recognize that the tobacco industry should be subject

6 to ongoing oversight.

7 (9) Under article I, section 8 of the Constitu8 tion, the Congress is vested with the responsibility

9 for regulating interstate commerce and commerce

10 with Indian tribes.

11 (10) The sale, distribution, marketing, adver12 tising, and use of tobacco products are activities in

13 and substantially affecting interstate commerce be14 cause they are sold, marketed, advertised, and dis15 tributed in interstate commerce on a nationwide

16 basis, and have a substantial effect on the Nation’s

17 economy.

18 (11) The sale, distribution, marketing, adver19 tising, and use of such products substantially affect

20 interstate commerce through the health care and

21 other costs attributable to the use of tobacco prod22 ucts.

23 (12) It is in the public interest for Congress to

24 adopt comprehensive public health legislation be25 cause of tobacco’s unique position in the Nation’s
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1 history and economy and the need to prevent the

2 sale, distribution, marketing and advertising of to3 bacco products to persons under the minimum legal

4 age to purchase such products.

5 (13) The public interest requires a timely, fair,

6 equitable, and consistent result that will serve the

7 public interest by restricting throughout the Nation

8 the sale, distribution, marketing, and advertising of

9 tobacco products only to persons of legal age to pur10 chase such products.

11 (14) Public health authorities estimate that the

12 benefits to the Nation of enacting Federal legislation

13 to accomplish these goals would be significant in

14 human and economic terms.

15 (15) Reducing the use of tobacco by minors by

16 50 percent would prevent well over 60,000 early

17 deaths each year and save up to $43 billion each

18 year in reduced medical costs, improved productivity,

19 and the avoidance of premature deaths.

20 (16) Advertising, marketing, and promotion of

21 tobacco products have been especially directed to at22 tract young persons to use tobacco products and

23 these efforts have resulted in increased use of such

24 products by youth. Past efforts to oversee these ac-
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1 tivities have not been successful in adequately pre2 venting such increased use.

3 (17) Tobacco advertising increases the size of

4 the tobacco market by increasing consumption of to5 bacco products including increasing tobacco use by

6 young people.

7 (18) Children are more influenced by tobacco

8 advertising than adults and they smoke the most ad9 vertised brands.

10 (19) Tobacco company documents indicate that

11 young people are an important and often crucial seg12 ment of the tobacco market.

13 (20) Advertising restrictions will have a positive

14 effect on the smoking rates of young people.

15 (21) Restrictions on advertising are necessary

16 to prevent unrestricted tobacco advertising from un17 dermining legislation prohibiting access to young

18 people.

19 (22) It is in the public interest for Congress to

20 adopt legislation to address the public health crisis

21 created by actions of the tobacco industry.

22 SEC. 3. DEFINITIONS.

23 (a) FEDERAL CIGARETTE LABELING AND ADVER24 TISING ACT.—Section 3(1) of the Federal Cigarette La25 beling and Advertising Act is amended—
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1 (1) in subparagraph (A) by striking ‘‘and’’;

2 (2) in subparagraph (B) by striking the period

3 and inserting ‘‘; and’’; and

4 (3) by inserting the following new subparagraph

5 at the end thereof:

6 ‘‘(C) any tobacco product, in any form, in7 cluding bidis and kreteks, if the tobacco in the

8 product is heated or burned and is functional in

9 the product, and the product, because of its ap10 pearance, the type of tobacco used in the filler,

11 or its packaging and labeling, is likely to be of12 fered to, or purchased by, consumers as a ciga13 rette or as roll-your-own tobacco.’’.

14 (b) THIS ACT.—In this Act:

15 (1) BRAND.—The term ‘‘brand’’ means a vari16 ety of tobacco product distinguished by the tobacco

17 used, tar content, nicotine content, flavoring used,

18 size, filtration, or packaging, logo, registered trade19 mark or brand name, identifiable pattern of colors,

20 or any combination of such attributes.

21 (2) CIGARETTE.—The term ‘‘cigarette’’ has the

22 meaning given that term by section 3(1) of the Fed23 eral Cigarette Labeling and Advertising Act (15

24 U.S.C. 1332(1)).
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1 (3) CIGARETTE TOBACCO.—The term ‘‘cigarette

2 tobacco’’ means any product that consists of loose

3 tobacco that is intended for use by consumers in a

4 cigarette. Unless otherwise stated, the requirements

5 for cigarettes shall also apply to cigarette tobacco.

6 (4) COMMERCE.—The term ‘‘commerce’’ has

7 the meaning given that term by section 3(2) of the

8 Federal Cigarette Labeling and Advertising Act (15

9 U.S.C. 1332(2)).

10 (5) CONSTITUENT.—The term ‘‘constituent’’ in

11 relation to cigarettes means any element of main12 stream or sidestream smoke.

13 (6) DISTRIBUTOR.—The term ‘‘distributor’’ as

14 regards a tobacco product means any person who

15 furthers the distribution of cigarette or smokeless to16 bacco, whether domestic or imported, at any point

17 from the original place of manufacture to the person

18 who sells or distributes the product to individuals for

19 personal consumption. Common carriers are not con20 sidered distributors for purposes of this Act.

21 (7) INGREDIENT.—The term ‘‘ingredient’’ in

22 relation to cigarettes or smokeless tobacco products

23 means any substance, chemical, or compound (other

24 than tobacco, water, or reconstituted tobacco sheet

25 made wholly from tobacco) added, or specified for
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1 addition, by the manufacturer to the tobacco, paper,

2 or filter of a cigarette, or to the tobacco of a smoke3 less tobacco product, including flavorants, processing

4 aids, casing sauces, preservatives, and combustion

5 modifiers.

6 (8) MANUFACTURER.—The term ‘‘manufac7 turer’’ means any person who manufactures tobacco

8 products intended to be sold in the United States.

9 The term ‘‘manufacturer’’ shall include an importer

10 or other first purchaser for resale in the United

11 States of tobacco products manufactured outside of

12 the United States or tobacco products manufactured

13 in the United States but not intended for sale in the

14 United States.

15 (9) NICOTINE.—The term ‘‘nicotine’’ means the

16 chemical substance named 3-(1-Methyl-2-

17 pyrrolidinyl) pyridine or C[10]H[14]N[2], including

18 any salt or complex of nicotine.

19 (10) PACKAGE.—The term ‘‘package’’ means a

20 pack, box, carton, or container of any kind or, if no

21 other container, any wrapping (including cello22 phane), in which cigarettes or smokeless tobacco are

23 offered for sale, sold, or otherwise distributed to con24 sumers.
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1 (11) RETAILER.—The term ‘‘retailer’’ means

2 any person who sells cigarettes or smokeless tobacco

3 to individuals for personal consumption, or who op4 erates a facility where self-service displays of tobacco

5 products are permitted.

6 (12) SECRETARY.—Except where the context

7 otherwise requires, the term ‘‘Secretary’’ means the

8 Secretary of Health and Human Services.

9 (13) SMOKELESS TOBACCO.—The term ‘‘smoke10 less tobacco’’ means any product that consists of

11 cut, ground, powdered, or leaf tobacco and that is

12 intended to be placed in the oral or nasal cavity.

13 SEC. 4. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS14 METIC ACT OF 1938.

15 (a) DEFINITION.—Section 201 of the Federal Food,

16 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by

17 adding at the end the following:

18 ‘‘(kk) The term ‘tobacco product’ means any

19 product made or derived from tobacco that is in20 tended for human consumption, including any com21 ponent, part, or accessory of a tobacco product (ex22 cept for raw materials other than tobacco used in

23 manufacturing a component, part, or accessory of a

24 tobacco product).
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1 ‘‘(ll) The definitions contained in section 3 of

2 the National Youth Smoking Reduction Act shall

3 apply with respect to chapter IX.’’.

4 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

5 The Federal Food, Drug, and Cosmetic Act (21 U.S.C.

6 301 et seq.) is amended—

7 (1) by redesignating chapter IX as chapter X;

8 (2) by redesignating sections 901 through 907

9 as sections 1001 through 1007; and

10 (3) by inserting after section 803 the following:

11 ‘‘CHAPTER IX—TOBACCO

12 PRODUCTS

13 ‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

14 ‘‘(a) IN GENERAL.—Tobacco products shall be regu15 lated by the Secretary under this chapter and shall not

16 be subject to the provisions of chapter V, unless—

17 ‘‘(1) such products are intended for use in the

18 diagnosis, cure, mitigation, treatment, or prevention

19 of disease (within the meaning of section

20 201(g)(1)(B) or section 201(h)(2)); or

21 ‘‘(2) a health claim is made for such products

22 under section 201(g)(1)(C) or 201(h)(3), unless the

23 product is a reduced risk product pursuant to sec24 tion 912.
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1 ‘‘(b) APPLICABILITY.—This chapter shall apply to all

2 tobacco products subject to the provisions of part 897 of

3 title 21, Code of Federal Regulations, and to any other

4 tobacco products that the Secretary by regulation deems

5 to be subject to this chapter.

6 ‘‘(c) SCOPE.—

7 ‘‘(1) Nothing in this chapter shall be construed

8 to affect the Secretary’s authority over, or the regu9 lation of, products under this Act that are not to10 bacco products under chapter V of the Federal

11 Food, Drug and Cosmetic Act or any other chapter

12 of that Act.

13 ‘‘(2) The provisions of this chapter shall not

14 apply to tobacco leaf that is not in the possession of

15 the manufacturer, or to the producers of tobacco

16 leaf, including tobacco growers, tobacco warehouses,

17 and tobacco grower cooperatives, nor shall any em18 ployee of the Food and Drug Administration have

19 any authority whatsoever to enter onto a farm

20 owned by a producer of tobacco leaf without the

21 written consent of such producer. Notwithstanding

22 any other provision of this subparagraph, if a pro23 ducer of tobacco leaf is also a tobacco product man24 ufacturer or controlled by a tobacco product manu25 facturer, the producer shall be subject to this chap-
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1 ter in the producer’s capacity as a manufacturer.

2 Nothing in this chapter shall be construed to grant

3 the Secretary authority to promulgate regulations on

4 any matter that involves the production of tobacco

5 leaf or a producer thereof, other than activities by

6 a manufacturer affecting production. For purposes

7 of the preceding sentence, the term ‘controlled by’

8 means a member of the same controlled group of

9 corporations as that term is used in section 52(a)

10 of the Internal Revenue Code of 1986, or under

11 common control within the meaning of the regula12 tions promulgated under section 52(b) of such Code.

13 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.

14 ‘‘A tobacco product shall be deemed to be adulterated

15 if—

16 ‘‘(1) it consists in whole or in part of any filthy,

17 putrid, or decomposed substance, or is otherwise

18 contaminated by any poisonous or deleterious sub19 stance that may render the product more injurious

20 to health;

21 ‘‘(2) it has been prepared, packed, or held

22 under insanitary conditions whereby it may have

23 been contaminated with filth, or whereby it may

24 have been rendered more injurious to health;
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1 ‘‘(3) its container is composed, in whole or in

2 part, of any poisonous or deleterious substance

3 which may render the contents more injurious to

4 health;

5 ‘‘(4) it is, or purports to be or is represented

6 as, a tobacco product which is subject to a perform7 ance standard established under section 907 unless

8 such tobacco product is in all respects in conformity

9 with such standard;

10 ‘‘(5) it is required by section 910(a) to have

11 premarket approval, is not exempt under section

12 906(f), and does not have an approved application in

13 effect;

14 ‘‘(6) the methods used in, or the facilities or

15 controls used for, its manufacture, packing or stor16 age are not in conformity with applicable require17 ments under section 906(e)(1) or an applicable con18 dition prescribed by an order under section

19 906(e)(2); or

20 ‘‘(7) it is a tobacco product for which an ex21 emption has been granted under section 906(f) for

22 investigational use and the person who was granted

23 such exemption or any investigator who uses such

24 tobacco product under such exemption fails to com-
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1 ply with a requirement prescribed by or under such

2 section.

3 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.

4 ‘‘(a) IN GENERAL.—A tobacco product shall be

5 deemed to be misbranded—

6 ‘‘(1) if its labeling is false or misleading in any

7 particular;

8 ‘‘(2) if in package form unless it bears a label

9 containing—

10 ‘‘(A) the name and place of business of the

11 tobacco product manufacturer, packer, or dis12 tributor; and

13 ‘‘(B) an accurate statement of the quantity

14 of the contents in terms of weight, measure, or

15 numerical count,

16 except that under subparagraph (B) of this para17 graph reasonable variations shall be permitted, and

18 exemptions as to small packages shall be established,

19 by regulations prescribed by the Secretary;

20 ‘‘(3) if any word, statement, or other informa21 tion required by or under authority of this chapter

22 to appear on the label or labeling is not prominently

23 placed thereon with such conspicuousness (as com24 pared with other words, statements or designs in the

25 labeling) and in such terms as to render it likely to
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1 be read and understood by the ordinary individual

2 under customary conditions of purchase and use;

3 ‘‘(4) if it has an established name, unless its

4 label bears, to the exclusion of any other nonpropri5 etary name, its established name prominently print6 ed in type as required by the Secretary by regula7 tion;

8 ‘‘(5) if the Secretary has issued regulations re9 quiring that its labeling bear adequate directions for

10 use, or adequate warnings against use by children,

11 that are necessary for the protection of users unless

12 its labeling conforms in all respects to such regula13 tions;

14 ‘‘(6) if it was manufactured, prepared, propa15 gated, compounded, or processed in any State in an

16 establishment not duly registered under section

17 905(b), if it was not included in a list required by

18 section 905(i), if a notice or other information re19 specting it was not provided as required by such sec20 tion or section 905(j), or if it does not bear such

21 symbols from the uniform system for identification

22 of tobacco products prescribed under section 905(e)

23 as the Secretary by regulation requires;

24 ‘‘(7) if, in the case of any tobacco product dis25 tributed or offered for sale in any State—
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1 ‘‘(A) its advertising is false or misleading

2 in any particular; or

3 ‘‘(B) it is sold, distributed, advertised, or

4 promoted in violation of section 915 or regula5 tions prescribed under section 906(d);

6 ‘‘(8) unless, in the case of any tobacco product

7 distributed or offered for sale in any State, the man8 ufacturer, packer, or distributor thereof includes in

9 all advertisements and other descriptive printed mat10 ter issued or caused to be issued by the manufac11 turer, packer, or distributor with respect to that to12 bacco product—

13 ‘‘(A) a true statement of the tobacco prod14 uct’s established name as defined in paragraph

15 (4) of this subsection, printed prominently; and

16 ‘‘(B) a brief statement of—

17 ‘‘(i) the uses of the tobacco product

18 and relevant warnings, precautions, side

19 effects, and contraindications; and

20 ‘‘(ii) in the case of specific tobacco

21 products made subject to a finding by the

22 Secretary after notice and opportunity for

23 comment that such action is necessary to

24 protect the public health, a full description

25 of the components of such tobacco product
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1 or the formula showing quantitatively each

2 ingredient of such tobacco product to the

3 extent required in regulations which shall

4 be issued by the Secretary after an oppor5 tunity for a hearing;

6 ‘‘(9) unless, in the case of any tobacco product

7 distributed or offered for sale in any State, the man8 ufacturer, packer, or distributor thereof includes in

9 all advertisements the information required by sec10 tion 916(c);

11 ‘‘(10) if it is a tobacco product subject to a per12 formance standard established under section 907,

13 unless it bears such labeling as may be prescribed in

14 such performance standard; or

15 ‘‘(11) if there was a failure or refusal—

16 ‘‘(A) to comply with any requirement pre17 scribed under section 904 or 908; or

18 ‘‘(B) to furnish any material or informa19 tion required by or under section 909.

20 ‘‘(b) PRIOR APPROVAL OF STATEMENTS ON

21 LABEL.—The Secretary may, by regulation, require prior

22 approval of statements made on the label of a tobacco

23 product. No regulation issued under this subsection may

24 require prior approval by the Secretary of the content of

25 any advertisement and no advertisement of a tobacco
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1 product, published after the date of enactment of this Act

2 shall, with respect to the matters specified in this section

3 or covered by regulations issued hereunder, be subject to

4 the provisions of sections 12 through 15 of the Federal

5 Trade Commission Act (15 U.S.C. 52 through 55). This

6 subsection does not apply to any printed matter which the

7 Secretary determines to be labeling as defined in section

8 201(m).

9 ‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE

10 SECRETARY.

11 ‘‘(a) REQUIREMENT.—Not later than 6 months after

12 the date of enactment of this Act, each tobacco product

13 manufacturer or importer of tobacco products, or agents

14 thereof, shall submit to the Secretary the following infor15 mation:

16 ‘‘(1) A listing of all tobacco ingredients, sub17 stances and compounds that are, on such date,

18 added by the manufacturer to the tobacco, paper, fil19 ter, or other component of each tobacco product by

20 brand and by quantity in each brand and subbrand.

21 ‘‘(2) A description of the content, delivery, and

22 form of nicotine in each tobacco product measured

23 in milligrams of nicotine.

24 ‘‘(3) All documents (including underlying sci25 entific information) relating to research activities,
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1 and research findings, conducted, supported, or pos2 sessed by the manufacturer (or agents thereof) on

3 the health, behavioral, or physiologic effects of to4 bacco products, their constituents, ingredients, and

5 components, and tobacco additives, described in

6 paragraph (1).

7 ‘‘(4) All documents (including underlying sci8 entific information) relating to research activities,

9 and research findings, conducted, supported, or pos10 sessed by the manufacturer (or agents thereof) that

11 relate to the issue of whether a reduction in risk to

12 health from tobacco products can occur upon the

13 employment of technology available or known to the

14 manufacturer.

15 ‘‘(5) All documents (including underlying sci16 entific information) relating to marketing research

17 involving the use of tobacco products.

18 An importer of a tobacco product not manufactured in the

19 United States shall supply the information required of a

20 tobacco product manufacturer under this subsection.

21 ‘‘(b) ANNUAL SUBMISSION.—A tobacco product man22 ufacturer or importer that is required to submit informa23 tion under subsection (a) shall update such information

24 on an annual basis under a schedule determined by the

25 Secretary.
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1 ‘‘(c) TIME FOR SUBMISSION.—

2 ‘‘(1) NEW PRODUCTS.—At least 90 days prior

3 to the delivery for introduction into interstate com4 merce of a tobacco product not on the market on the

5 date of enactment of this chapter, the manufacturer

6 of such product shall provide the information re7 quired under subsection (a) and such product shall

8 be subject to the annual submission under sub9 section (b).

10 ‘‘(2) MODIFICATION OF EXISTING PRODUCTS.—

11 If at any time a tobacco product manufacturer adds

12 to its tobacco products a new tobacco additive, in13 creases or decreases the quantity of an existing to14 bacco additive or the nicotine content, delivery, or

15 form, or eliminates a tobacco additive from any to16 bacco product, the manufacturer shall within 60

17 days of such action so advise the Secretary in writ18 ing and reference such modification in submissions

19 made under subsection (b).

20 ‘‘SEC. 905. ANNUAL REGISTRATION.

21 ‘‘(a) DEFINITIONS.—As used in this section—

22 ‘‘(1) consistent with the provisions of section

23 901(c)(2), the term ‘manufacture, preparation,

24 compounding, or processing’ shall include repack25 aging or otherwise changing the container, wrapper,
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1 or labeling of any tobacco product package in fur2 therance of the distribution of the tobacco product

3 from the original place of manufacture to the person

4 who makes final delivery or sale to the ultimate con5 sumer or user; and

6 ‘‘(2) the term ‘name’ shall include in the case

7 of a partnership the name of each partner and, in

8 the case of a corporation, the name of each cor9 porate officer and director, and the State of incorpo10 ration.

11 ‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.—

12 On or before December 31 of each year every person who

13 owns or operates any establishment in any State engaged

14 in the manufacture, preparation, compounding, or proc15 essing of a tobacco product or tobacco products shall reg16 ister with the Secretary the name, places of business, and

17 all such establishments of that person.

18 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA19 TORS.—Every person upon first engaging in the manufac20 ture, preparation, compounding, or processing of a tobacco

21 product or tobacco products in any establishment owned

22 or operated in any State by that person shall immediately

23 register with the Secretary that person’s name, place of

24 business, and such establishment.
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1 ‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—

2 Every person required to register under subsection (b) or

3 (c) shall immediately register with the Secretary any addi4 tional establishment which that person owns or operates

5 in any State and in which that person begins the manufac6 ture, preparation, compounding, or processing of a tobacco

7 product or tobacco products.

8 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS9 TEM.—The Secretary may by regulation prescribe a uni10 form system for the identification of tobacco products and

11 may require that persons who are required to list such

12 tobacco products under subsection (i) of this section shall

13 list such tobacco products in accordance with such system.

14 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA15 TION.—The Secretary shall make available for inspection,

16 to any person so requesting, any registration filed under

17 this section.

18 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB19 LISHMENTS.—Every establishment in any State registered

20 with the Secretary under this section shall be subject to

21 inspection under section 704, and every such establish22 ment engaged in the manufacture, compounding, or proc23 essing of a tobacco product or tobacco products shall be

24 so inspected by one or more officers or employees duly

25 designated by the Secretary at least once in the 2-year
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1 period beginning with the date of registration of such es2 tablishment under this section and at least once in every

3 successive 2-year period thereafter.

4 ‘‘(h) FOREIGN ESTABLISHMENTS MAY REGISTER.—

5 Any establishment within any foreign country engaged in

6 the manufacture, preparation, compounding, or processing

7 of a tobacco product or tobacco products, may register

8 under this section under regulations promulgated by the

9 Secretary. Such regulations shall require such establish10 ment to provide the information required by subsection (i)

11 of this section and shall include provisions for registration

12 of any such establishment upon condition that adequate

13 and effective means are available, by arrangement with the

14 government of such foreign country or otherwise, to enable

15 the Secretary to determine from time to time whether to16 bacco products manufactured, prepared, compounded, or

17 processed in such establishment, if imported or offered for

18 import into the United States, shall be refused admission

19 on any of the grounds set forth in section 801(a).

20 ‘‘(i) REGISTRATION INFORMATION.—

21 ‘‘(1) PRODUCT LIST.—Every person who reg22 isters with the Secretary under subsection (b), (c),

23 or (d) of this section shall, at the time of registra24 tion under any such subsection, file with the Sec25 retary a list of all tobacco products which are being
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1 manufactured, prepared, compounded, or processed

2 by that person for commercial distribution and

3 which has not been included in any list of tobacco

4 products filed by that person with the Secretary

5 under this paragraph or paragraph (2) before such

6 time of registration. Such list shall be prepared in

7 such form and manner as the Secretary may pre8 scribe and shall be accompanied by—

9 ‘‘(A) in the case of a tobacco product con10 tained in the applicable list with respect to

11 which a performance standard has been estab12 lished under section 907 or which is subject to

13 section 910, a reference to the authority for the

14 marketing of such tobacco product and a copy

15 of all labeling for such tobacco product;

16 ‘‘(B) in the case of any other tobacco prod17 uct contained in an applicable list, a copy of all

18 consumer information and other labeling for

19 such tobacco product, a representative sampling

20 of advertisements for such tobacco product,

21 and, upon request made by the Secretary for

22 good cause, a copy of all advertisements for a

23 particular tobacco product; and

24 ‘‘(C) if the registrant filing a list has de25 termined that a tobacco product contained in
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1 such list is not subject to a performance stand2 ard established under section 907, a brief state3 ment of the basis upon which the registrant

4 made such determination if the Secretary re5 quests such a statement with respect to that

6 particular tobacco product.

7 ‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN

8 PRODUCT LIST.—Each person who registers with the

9 Secretary under this section shall report to the Sec10 retary once during the month of June of each year

11 and once during the month of December of each

12 year the following:

13 ‘‘(A) A list of each tobacco product intro14 duced by the registrant for commercial distribu15 tion which has not been included in any list

16 previously filed by that person with the Sec17 retary under this subparagraph or paragraph

18 (1) of this subsection. A list under this sub19 paragraph shall list a tobacco product by its es20 tablished name and shall be accompanied by the

21 other information required by paragraph (1).

22 ‘‘(B) If since the date the registrant last

23 made a report under this paragraph that person

24 has discontinued the manufacture, preparation,

25 compounding, or processing for commercial dis-
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1 tribution of a tobacco product included in a list

2 filed under subparagraph (A) or paragraph (1),

3 notice of such discontinuance, the date of such

4 discontinuance, and the identity of its estab5 lished name.

6 ‘‘(C) If since the date the registrant re7 ported under subparagraph (B) a notice of dis8 continuance that person has resumed the manu9 facture, preparation, compounding, or proc10 essing for commercial distribution of the to11 bacco product with respect to which such notice

12 of discontinuance was reported, notice of such

13 resumption, the date of such resumption, the

14 identity of such tobacco product by established

15 name, and other information required by para16 graph (1), unless the registrant has previously

17 reported such resumption to the Secretary

18 under this subparagraph.

19 ‘‘(D) Any material change in any informa20 tion previously submitted under this paragraph

21 or paragraph (1).

22 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER23 TAIN SUBSTANTIALLY EQUIVALENT PRODUCTS INTO

24 INTERSTATE COMMERCE.—Each person who is required

25 to register under this section and who proposes to begin
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1 the introduction or delivery for introduction into interstate

2 commerce for commercial distribution of a tobacco product

3 intended for human use that was not commercially mar4 keted (other than for test marketing) in the United States

5 as of the date of enactment of this Act, as defined by the

6 Secretary by regulation shall, at least 90 days before mak7 ing such introduction or delivery, report to the Secretary

8 (in such form and manner as the Secretary shall by regu9 lation prescribe)—

10 ‘‘(1) the basis for such person’s determination

11 that the tobacco product is substantially equivalent,

12 within the meaning of section 910, to a tobacco

13 product commercially marketed (other than for test

14 marketing) in the United States as of the date of

15 this Act’s enactment, that is in compliance with the

16 requirements of this Act; and

17 ‘‘(2) action taken by such person to comply

18 with the requirements under section 907 that are

19 applicable to the tobacco product.

20 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL

21 OF TOBACCO PRODUCTS.

22 ‘‘(a) IN GENERAL.—Any requirement established by

23 or under section 902, 903, 905, or 909 applicable to a

24 tobacco product shall apply to such tobacco product until

25 the applicability of the requirement to the tobacco product
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1 has been changed by action taken under section 907, sec2 tion 910, or subsection (d) of this section, and any re3 quirement established by or under section 902, 903, 905,

4 or 909 which is inconsistent with a requirement imposed

5 on such tobacco product under section 907, section 910,

6 or subsection (d) of this section shall not apply to such

7 tobacco product.

8 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM9 MENT.—Each notice of proposed rulemaking under section

10 907, 908, 909, or 910, or under this section, any other

11 notice which is published in the Federal Register with re12 spect to any other action taken under any such section

13 and which states the reasons for such action, and each

14 publication of findings required to be made in connection

15 with rulemaking under any such section shall set forth—

16 ‘‘(1) the manner in which interested persons

17 may examine data and other information on which

18 the notice or findings is based; and

19 ‘‘(2) the period within which interested persons

20 may present their comments on the notice or find21 ings (including the need thereof) orally or in writing,

22 which period shall be at least 60 days but may not

23 exceed 90 days unless the time is extended by the

24 Secretary by a notice published in the Federal Reg25 ister stating good cause therefor.
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1 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA2 TION.—Any information reported to or otherwise obtained

3 by the Secretary or the Secretary’s representative under

4 section 904, 905, 907, 908, 909, 910, 912, or 704, or

5 under subsection (e) or (f) of this section, which is exempt

6 from disclosure under subsection (a) of section 552 of title

7 5, United States Code, by reason of subsection (b)(4) of

8 that section shall be considered confidential and shall not

9 be disclosed, except that the information may be disclosed

10 to other officers or employees concerned with carrying out

11 this chapter, or when relevant in any proceeding under

12 this chapter.

13 ‘‘(d) RESTRICTIONS.—

14 ‘‘(1) The Secretary may by regulation require

15 that a tobacco product be restricted to sale or dis16 tribution upon such conditions, including restrictions

17 on the access to, and the advertising and promotion

18 of, the tobacco product, as the Secretary may pre19 scribe in such regulation if the Secretary determines

20 that such regulation would be appropriate for the

21 prevention of, or decrease in, the use of tobacco

22 products by children under the age at which tobacco

23 products may be legally purchased. No such condi24 tion may require that the sale or distribution of a

25 tobacco product be limited to the written or oral au-
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1 thorization of a practitioner licensed by law to pre2 scribe medical products.

3 ‘‘(2) The label of a tobacco product shall bear

4 such appropriate statements of the restrictions re5 quired by a regulation under subsection (a) as the

6 Secretary may in such regulation prescribe.

7 ‘‘(3) No restriction under paragraph (1) may

8 prohibit the sale of any tobacco product in face-to9 face transactions by a specific category of retail out10 lets.

11 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE12 MENTS.—

13 ‘‘(1) METHODS, FACILITIES, AND CONTROLS TO

14 CONFORM.—

15 ‘‘(A) The Secretary may, in accordance

16 with subparagraph (B), prescribe regulations

17 requiring that the methods used in, and the fa18 cilities and controls used for, the manufacture,

19 pre-production design validation (including a

20 process to assess the performance of a tobacco

21 product), packing and storage of a tobacco

22 product, conform to current good manufac23 turing practice for an agricultural product, as

24 prescribed in such regulations, to assure that

25 the public health is protected and that the to-
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1 bacco product is in compliance with this chap2 ter.

3 ‘‘(B) The Secretary shall—

4 ‘‘(i) before promulgating any regula5 tion under subparagraph (A), afford an ad6 visory committee an opportunity to submit

7 recommendations with respect to the regu8 lation proposed to be promulgated;

9 ‘‘(ii) before promulgating any regula10 tion under subparagraph (A), afford oppor11 tunity for an oral hearing;

12 ‘‘(iii) provide the advisory committee a

13 reasonable time to make its recommenda14 tion with respect to proposed regulations

15 under subparagraph (A); and

16 ‘‘(iv) in establishing the effective date

17 of a regulation promulgated under this

18 subsection, take into account the dif19 ferences in the manner in which the dif20 ferent types of tobacco products have his21 torically been produced, the financial re22 sources of the different tobacco product

23 manufacturers, and the state of their exist24 ing manufacturing facilities; and shall pro25 vide for a reasonable period of time for
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1 such manufacturers to conform to good

2 manufacturing practices.

3 ‘‘(2) EXEMPTIONS; VARIANCES.—

4 ‘‘(A) Any person subject to any require5 ment prescribed under paragraph (1) may peti6 tion the Secretary for a permanent or tem7 porary exemption or variance from such re8 quirement. Such a petition shall be submitted

9 to the Secretary in such form and manner as

10 the Secretary shall prescribe and shall—

11 ‘‘(i) in the case of a petition for an ex12 emption from a requirement, set forth the

13 basis for the petitioner’s determination

14 that compliance with the requirement is

15 not required to assure that the tobacco

16 product will be in compliance with this

17 chapter;

18 ‘‘(ii) in the case of a petition for a

19 variance from a requirement, set forth the

20 methods proposed to be used in, and the

21 facilities and controls proposed to be used

22 for, the manufacture, packing, and storage

23 of the tobacco product in lieu of the meth24 ods, facilities, and controls prescribed by

25 the requirement; and
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1 ‘‘(iii) contain such other information

2 as the Secretary shall prescribe.

3 ‘‘(B) The Secretary may refer to an advi4 sory committee any petition submitted under

5 subparagraph (A). The advisory committee

6 shall report its recommendations to the Sec7 retary with respect to a petition referred to it

8 within 60 days after the date of the petition’s

9 referral. Within 60 days after—

10 ‘‘(i) the date the petition was sub11 mitted to the Secretary under subpara12 graph (A); or

13 ‘‘(ii) the day after the petition was re14 ferred to an advisory committee,

15 whichever occurs later, the Secretary shall by

16 order either deny the petition or approve it.

17 ‘‘(C) The Secretary may approve—

18 ‘‘(i) a petition for an exemption for a

19 tobacco product from a requirement if the

20 Secretary determines that compliance with

21 such requirement is not required to assure

22 that the tobacco product will be in compli23 ance with this chapter; and

24 ‘‘(ii) a petition for a variance for a to25 bacco product from a requirement if the
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1 Secretary determines that the methods to

2 be used in, and the facilities and controls

3 to be used for, the manufacture, packing,

4 and storage of the tobacco product in lieu

5 of the methods, controls, and facilities pre6 scribed by the requirement are sufficient to

7 assure that the tobacco product will be in

8 compliance with this chapter.

9 ‘‘(D) An order of the Secretary approving

10 a petition for a variance shall prescribe such

11 conditions respecting the methods used in, and

12 the facilities and controls used for, the manu13 facture, packing, and storage of the tobacco

14 product to be granted the variance under the

15 petition as may be necessary to assure that the

16 tobacco product will be in compliance with this

17 chapter.

18 ‘‘(E) After the issuance of an order under

19 subparagraph (B) respecting a petition, the pe20 titioner shall have an opportunity for an infor21 mal hearing on such order.

22 ‘‘(f) EXEMPTION FOR INVESTIGATIONAL USE.—The

23 Secretary may exempt tobacco products intended for in24 vestigational use from this chapter under such conditions

25 as the Secretary may prescribe by regulation.
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1 ‘‘(g) RESEARCH AND DEVELOPMENT.—The Sec2 retary may enter into contracts for research, testing, and

3 demonstrations respecting tobacco products and may ob4 tain tobacco products for research, testing, and dem5 onstration purposes without regard to section 3324(a) and

6 (b) of title 31, United States Code, and section 5 of title

7 41, United States Code.

8 ‘‘SEC. 907. PERFORMANCE STANDARDS.

9 ‘‘(a) IN GENERAL.—

10 ‘‘(1) FINDING REQUIRED.—The Secretary may

11 adopt performance standards for a tobacco product

12 if the Secretary finds that a performance standard

13 is appropriate for the protection of the public health.

14 This finding shall be determined with respect to the

15 risks and benefits to the population as a whole, in16 cluding users and non-users of the tobacco product,

17 and taking into account—

18 ‘‘(A) the increased or decreased likelihood

19 that existing users of tobacco products will stop

20 using such products; and

21 ‘‘(B) the increased or decreased likelihood

22 that those who do not use tobacco products will

23 start using such products.
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1 ‘‘(2) CONTENT OF PERFORMANCE STAND2 ARDS.—A performance standard established under

3 this section for a tobacco product—

4 ‘‘(A) shall include provisions to provide

5 performance that is appropriate for the protec6 tion of the public health, including provisions,

7 where appropriate—

8 ‘‘(i) for the reduction of nicotine

9 yields of the product;

10 ‘‘(ii) for the reduction or elimination

11 of other harmful constituents or harmful

12 components of the product; or

13 ‘‘(iii) relating to any other require14 ment under (B);

15 ‘‘(B) shall, where necessary to be appro16 priate for the protection of the public health,

17 include—

18 ‘‘(i) provisions respecting the con19 struction, components, ingredients, and

20 properties of the tobacco product;

21 ‘‘(ii) provisions for the testing (on a

22 sample basis or, if necessary, on an indi23 vidual basis) of the tobacco product;
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1 ‘‘(iii) provisions for the measurement

2 of the performance characteristics of the

3 tobacco product; and

4 ‘‘(iv) provisions requiring that the re5 sults of each or of certain of the tests of

6 the tobacco product required to be made

7 under clause (ii) show that the tobacco

8 product is in conformity with the portions

9 of the standard for which the test or tests

10 were required; and

11 ‘‘(C) shall not render the tobacco product

12 unacceptable for adult consumption.

13 ‘‘(3) PERIODIC REEVALUATION OF PERFORM14 ANCE STANDARDS.—The Secretary shall provide for

15 periodic evaluation of performance standards estab16 lished under this section to determine whether such

17 standards should be changed to reflect new medical,

18 scientific, or other technological data. The Secretary

19 may provide for testing under paragraph (2) by any

20 person.

21 ‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN22 FORMED PERSONS.—In carrying out duties under

23 this section, the Secretary shall, to the maximum ex24 tent practicable—
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1 ‘‘(A) use personnel, facilities, and other

2 technical support available in other Federal

3 agencies;

4 ‘‘(B) consult with other Federal agencies

5 concerned with standard-setting and other na6 tionally or internationally recognized standard7 setting entities; and

8 ‘‘(C) invite appropriate participation,

9 through joint or other conferences, workshops,

10 or other means, by informed persons represent11 ative of scientific, professional, industry, or con12 sumer organizations who in the Secretary’s

13 judgment can make a significant contribution.

14 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

15 ‘‘(1) NOTICE.—

16 ‘‘(A) The Secretary shall publish in the

17 Federal Register a notice of proposed rule18 making for the establishment, amendment, or

19 revocation of any performance standard for a

20 tobacco product.

21 ‘‘(B) A notice of proposed rulemaking for

22 the establishment or amendment of a perform23 ance standard for a tobacco product shall—

24 ‘‘(i) set forth a finding with sup25 porting justification that the performance
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1 standard is appropriate for the protection

2 of the public health;

3 ‘‘(ii) set forth proposed findings with

4 respect to the risk of illness or injury that

5 the performance standard is intended to

6 reduce or eliminate; and

7 ‘‘(iii) invite interested persons to sub8 mit an existing performance standard for

9 the tobacco product, including a draft or

10 proposed performance standard, for consid11 eration by the Secretary.

12 ‘‘(C) A notice of proposed rulemaking for

13 the revocation of a performance standard shall

14 set forth a finding with supporting justification

15 that the performance standard is no longer nec16 essary to be appropriate for the protection of

17 the public health.

18 ‘‘(D) The Secretary shall consider all infor19 mation submitted in connection with a proposed

20 standard, including information concerning the

21 countervailing effects of the performance stand22 ard on the health of adolescent tobacco users,

23 adult tobacco users, or non-tobacco users, such

24 as the creation of a significant demand for con25 traband or other tobacco products that do not
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1 meet the requirements of this chapter and the

2 significance of such demand, and shall issue the

3 standard if the Secretary determines that the

4 standard would be appropriate for the protec5 tion of the public health.

6 ‘‘(E) The Secretary shall provide for a

7 comment period of not less than 60 days.

8 ‘‘(2) PROMULGATION.—

9 ‘‘(A) After the expiration of the period for

10 comment on a notice of proposed rulemaking

11 published under paragraph (1) respecting a per12 formance standard and after consideration of

13 such comments and any report from an advi14 sory committee, the Secretary shall—

15 ‘‘(i) promulgate a regulation estab16 lishing a performance standard and pub17 lish in the Federal Register findings on the

18 matters referred to in paragraph (1); or

19 ‘‘(ii) publish a notice terminating the

20 proceeding for the development of the

21 standard together with the reasons for

22 such termination.

23 ‘‘(B) A regulation establishing a perform24 ance standard shall set forth the date or dates

25 upon which the standard shall take effect, but
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1 no such regulation may take effect before one

2 year after the date of its publication unless the

3 Secretary determines that an earlier effective

4 date is necessary for the protection of the pub5 lic health. Such date or dates shall be estab6 lished so as to minimize, consistent with the

7 public health, economic loss to, and disruption

8 or dislocation of, domestic and international

9 trade.

10 ‘‘(3) POWER RESERVED TO CONGRESS.—Be11 cause of the importance of any decision to issue a

12 regulation establishing a performance standard—

13 ‘‘(A) eliminating all cigarettes, all smoke14 less tobacco products, or any similar class of to15 bacco products, or

16 ‘‘(B) requiring the reduction of nicotine

17 yields of a tobacco product to zero,

18 Congress expressly reserves to itself the power to

19 make such a decision.

20 ‘‘(4) AMENDMENT; REVOCATION.—

21 ‘‘(A) The Secretary, upon the Secretary’s

22 own initiative or upon petition of an interested

23 person may by a regulation, promulgated in ac24 cordance with the requirements of paragraphs
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1 (1) and (2)(B) of this subsection, amend or re2 voke a performance standard.

3 ‘‘(B) The Secretary may declare a pro4 posed amendment of a performance standard to

5 be effective on and after its publication in the

6 Federal Register and until the effective date of

7 any final action taken on such amendment if

8 the Secretary determines that making it so ef9 fective is in the public interest.

10 ‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—

11 The Secretary—

12 ‘‘(A) may, on the Secretary’s own initia13 tive, refer a proposed regulation for the estab14 lishment, amendment, or revocation of a per15 formance standard; or

16 ‘‘(B) shall, upon the request of an inter17 ested person which demonstrates good cause for

18 referral and which is made before the expiration

19 of the period for submission of comments on

20 such proposed regulation,

21 refer such proposed regulation to an advisory com22 mittee, for a report and recommendation with re23 spect to any matter involved in the proposed regula24 tion which requires the exercise of scientific judg25 ment. If a proposed regulation is referred under this
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1 subparagraph to the advisory committee, the Sec2 retary shall provide the advisory committee with the

3 data and information on which such proposed regu4 lation is based. The advisory committee shall, within

5 60 days after the referral of a proposed regulation

6 and after independent study of the data and infor7 mation furnished to it by the Secretary and other

8 data and information before it, submit to the Sec9 retary a report and recommendation respecting such

10 regulation, together with all underlying data and in11 formation and a statement of the reason or basis for

12 the recommendation. A copy of such report and rec13 ommendation shall be made public by the Secretary.

14 ‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES.

15 ‘‘(a) NOTIFICATION.—If the Secretary determines

16 that—

17 ‘‘(1) a tobacco product which is introduced or

18 delivered for introduction into interstate commerce

19 for commercial distribution presents a risk of sub20 stantial harm to the public health exceeding the

21 risks posed by tobacco products marketed before the

22 date of enactment of this Act; and

23 ‘‘(2) notification under this subsection is nec24 essary to eliminate the unreasonable risk of such

25 harm and no more practicable means is available
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1 under the provisions of this chapter (other than this

2 section) to eliminate such risk,

3 the Secretary may issue such order as may be necessary

4 to assure that adequate notification is provided in an ap5 propriate form, by the persons and means best suited

6 under the circumstances involved, to all persons who

7 should properly receive such notification in order to elimi8 nate such risk. The Secretary may order notification by

9 any appropriate means, including public service announce10 ments. Before issuing an order under this subsection, the

11 Secretary shall consult with the persons who are to give

12 notice under the order.

13 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.—

14 Compliance with an order issued under this section shall

15 not relieve any person from liability under Federal or

16 State law.

17 ‘‘(c) RECALL AUTHORITY.—

18 ‘‘(1) IN GENERAL.—If the Secretary finds that

19 there is a reasonable probability that a tobacco prod20 uct contains a manufacturing or other defect not or21 dinarily contained in tobacco products on the market

22 that would cause serious, adverse health con23 sequences or death, the Secretary shall issue an

24 order requiring the appropriate person (including

25 the manufacturers, importers, distributors, or retail-
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1 ers of the tobacco product) to immediately cease dis2 tribution of such tobacco product. The order shall

3 provide the person subject to the order with an op4 portunity for an informal hearing, to be held not

5 later than 10 days after the date of the issuance of

6 the order, on the actions required by the order and

7 on whether the order should be amended to require

8 a recall of such tobacco product. If, after providing

9 an opportunity for such a hearing, the Secretary de10 termines that inadequate grounds exist to support

11 the actions required by the order, the Secretary shall

12 vacate the order.

13 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE14 CALL.—

15 ‘‘(A) If, after providing an opportunity for

16 an informal hearing under paragraph (1), the

17 Secretary determines that the order should be

18 amended to include a recall of the tobacco prod19 uct with respect to which the order was issued,

20 the Secretary shall, except as provided in sub21 paragraph (B), amend the order to require a

22 recall. The Secretary shall specify a timetable in

23 which the tobacco product recall will occur and

24 shall require periodic reports to the Secretary

25 describing the progress of the recall.
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1 ‘‘(B) An amended order under subpara2 graph (A)—

3 ‘‘(i) shall not include recall of a to4 bacco product from individuals; and

5 ‘‘(ii) shall provide for notice to per6 sons subject to the risks associated with

7 the use of such tobacco product.

8 In providing the notice required by clause (ii),

9 the Secretary may use the assistance of retail10 ers and other persons who distributed such to11 bacco product. If a significant number of such

12 persons cannot be identified, the Secretary shall

13 notify such persons under section 705(b).

14 ‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy

15 provided by this subsection shall be in addition to

16 remedies provided by subsection (a) of this section.

17 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD18 UCTS.

19 ‘‘(a) IN GENERAL.—Every person who is a tobacco

20 product manufacturer or importer of a tobacco product

21 shall establish and maintain such records, make such re22 ports, and provide such information, as the Secretary may

23 by regulation reasonably require to assure that such to24 bacco product is not adulterated or misbranded and to
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1 otherwise protect public health. Regulations prescribed

2 under the preceding sentence—

3 ‘‘(1) may require a tobacco product manufac4 turer or importer to report to the Secretary when5 ever the manufacturer or importer receives or other6 wise becomes aware of information that reasonably

7 suggests that one of its marketed tobacco products

8 may have caused or contributed to a serious unex9 pected adverse experience associated with the use of

10 the product or any significant increase in the fre11 quency of a serious, expected adverse product experi12 ence;

13 ‘‘(2) shall require reporting of other significant

14 adverse tobacco product experiences as determined

15 by the Secretary to be necessary to be reported;

16 ‘‘(3) shall not impose requirements unduly bur17 densome to a tobacco product manufacturer or im18 porter, taking into account the cost of complying

19 with such requirements and the need for the protec20 tion of the public health and the implementation of

21 this chapter;

22 ‘‘(4) when prescribing the procedure for making

23 requests for reports or information, shall require

24 that each request made under such regulations for

25 submission of a report or information to the Sec-
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1 retary state the reason or purpose for such request

2 and identify to the fullest extent practicable such re3 port or information;

4 ‘‘(5) when requiring submission of a report or

5 information to the Secretary, shall state the reason

6 or purpose for the submission of such report or in7 formation and identify to the fullest extent prac8 ticable such report or information; and

9 ‘‘(6) may not require that the identity of any

10 patient or user be disclosed in records, reports, or

11 information required under this subsection unless re12 quired for the medical welfare of an individual, to

13 determine risks to public health of a tobacco prod14 uct, or to verify a record, report, or information sub15 mitted under this chapter.

16 In prescribing regulations under this subsection, the Sec17 retary shall have due regard for the professional ethics of

18 the medical profession and the interests of patients. The

19 prohibitions of paragraph (6) of this subsection continue

20 to apply to records, reports, and information concerning

21 any individual who has been a patient, irrespective of

22 whether or when he ceases to be a patient.

23 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—

24 (1) Except as provided in paragraph (3), the

25 Secretary shall by regulation require a tobacco prod-
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1 uct manufacturer or importer of a tobacco product

2 to report promptly to the Secretary any corrective

3 action taken or removal from the market of a to4 bacco product undertaken by such manufacturer or

5 importer if the removal or correction was

6 undertaken—

7 ‘‘(A) to reduce a risk to health posed by

8 the tobacco product; or

9 ‘‘(B) to remedy a violation of this chapter

10 caused by the tobacco product which may

11 present a risk to health.

12 A tobacco product manufacturer or importer of a tobacco

13 product who undertakes a corrective action or removal

14 from the market of a tobacco product which is not re15 quired to be reported under this subsection shall keep a

16 record of such correction or removal.

17 ‘‘(2) No report of the corrective action or re18 moval of a tobacco product may be required under

19 paragraph (1) if a report of the corrective action or

20 removal is required and has been submitted under

21 subsection (a) of this section.

22 ‘‘SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO

23 PRODUCTS.

24 ‘‘(a) IN GENERAL.—
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1 ‘‘(1) PREMARKET APPROVAL REQUIRED.—Ap2 proval under this section of an application for pre3 market approval for any tobacco product, other than

4 a reduced risk product under section 912, that is not

5 commercially marketed (other than for test mar6 keting) in the United States as of the date of this

7 Act’s enactment, is required unless the manufacturer

8 has submitted a report under section 905(j), and the

9 Secretary has not suspended the distribution of such

10 product under this paragraph. Within 90 days of the

11 submission of a report under section 905(j), the Sec12 retary may by order suspend the distribution of the

13 tobacco product that is the subject of that report if

14 the Secretary determines that there is a reasonable

15 likelihood that the tobacco product is not substan16 tially equivalent to a tobacco product commercially

17 marketed (other than for test marketing) in the

18 United States as of the date of this Act’s enactment,

19 that is in compliance with the requirements of this

20 Act. If the Secretary fails to issue an order within

21 this 90-day period, then the tobacco product that is

22 the subject of that report shall be deemed to be sub23 stantially equivalent to a predicate tobacco product.

24 The issuance of an order under this paragraph shall

25 constitute final agency action for purposes of section
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1 702 of title 5, the United States Code; provided,

2 that the Secretary may rescind or modify an order

3 issued under this paragraph at any time.

4 ‘‘(2) SUBSTANTIALLY EQUIVALENT DEFINED.—

5 ‘‘(A) For purposes of this section and sec6 tion 905(j), the term ‘substantially equivalent’

7 or ‘substantial equivalence’ mean, with respect

8 to the tobacco product being compared to the

9 predicate tobacco product, that the Secretary by

10 order has found that the tobacco product—

11 ‘‘(i) has the same characteristics as

12 the predicate tobacco product; or

13 ‘‘(ii) has different characteristics and

14 the information submitted contains infor15 mation, including clinical data if deemed

16 necessary by the Secretary, that dem17 onstrates that it is not appropriate to reg18 ulate the product under this section be19 cause the product could not reasonably be

20 expected to increase the health risks to

21 consumers compared to a conventional to22 bacco product that is commercially mar23 keted in the United States and that is in

24 compliance with the requirements of this

25 Act.
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1 ‘‘(B) For purposes of subparagraph (A),

2 the term ‘characteristics’ means the materials,

3 ingredients, design, composition, heating source,

4 or other features of a tobacco product.

5 ‘‘(C) A tobacco product may not be found

6 to be substantially equivalent to a predicate to7 bacco product that has been removed from the

8 market at the initiative of the Secretary or that

9 has been determined by a judicial order to be

10 misbranded or adulterated.

11 ‘‘(3) HEALTH INFORMATION.—

12 ‘‘(A) As part of a submission under section

13 905(j) respecting a tobacco product, the person

14 required to file a premarket notification under

15 such section shall provide an adequate summary

16 of any health information related to the tobacco

17 product or state that such information will be

18 made available upon request by any person.

19 ‘‘(B) Any summary under subparagraph

20 (A) respecting a tobacco product shall contain

21 detailed information regarding data concerning

22 adverse health effects and shall be made avail23 able to the public by the Secretary within 30

24 days of the issuance of a determination that

25 such tobacco product is substantially equivalent
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1 to another tobacco product. The communication

2 that such product is a reduced risk product

3 may comply with requirements prescribed by

4 the Secretary relating to such communication,

5 and the Secretary may require prior approval

6 of the communication, in each case in accord7 ance with section 912.

8 ‘‘(b) APPLICATION.—

9 ‘‘(1) CONTENTS.—An application for premarket

10 approval shall contain—

11 ‘‘(A) full reports of all information, pub12 lished or known to or which should reasonably

13 be known to the applicant, concerning investiga14 tions which have been made to show the health

15 risks of such tobacco product and whether such

16 tobacco product presents greater risk than

17 other tobacco products;

18 ‘‘(B) a full statement of the components,

19 ingredients, and properties, and of the principle

20 or principles of operation, of such tobacco prod21 uct;

22 ‘‘(C) a full description of the methods used

23 in, and the facilities and controls used for, the

24 manufacture, processing, and, when relevant,
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1 packing and installation of, such tobacco prod2 uct;

3 ‘‘(D) an identifying reference to any per4 formance standard under section 907 which

5 would be applicable to any aspect of such to6 bacco product, and either adequate information

7 to show that such aspect of such tobacco prod8 uct fully meets such performance standard or

9 adequate information to justify any deviation

10 from such standard;

11 ‘‘(E) such samples of such tobacco product

12 and of components thereof as the Secretary

13 may reasonably require;

14 ‘‘(F) specimens of the labeling proposed to

15 be used for such tobacco product; and

16 ‘‘(G) such other information relevant to

17 the subject matter of the application as the Sec18 retary may require.

19 ‘‘(2) REFERENCE TO ADVISORY COMMITTEE.—

20 Upon receipt of an application meeting the require21 ments set forth in paragraph (1), the Secretary—

22 ‘‘(A) may, on the Secretary’s own initia23 tive; or

24 ‘‘(B) shall, upon the request of an appli25 cant,
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1 refer such application to an advisory committee and

2 for submission (within such period as the Secretary

3 may establish) of a report and recommendation re4 specting approval of the application, together with

5 all underlying data and the reasons or basis for the

6 recommendation.

7 ‘‘(c) ACTION ON APPLICATION.—

8 ‘‘(1) DEADLINE.—

9 ‘‘(A) As promptly as possible, but in no

10 event later than 180 days after the receipt of

11 an application under subsection (b) of this sec12 tion, the Secretary, after considering the report

13 and recommendation submitted under para14 graph (2) of such subsection, shall—

15 ‘‘(i) issue an order approving the ap16 plication if the Secretary finds that none of

17 the grounds for denying approval specified

18 in paragraph (2) of this subsection applies;

19 or

20 ‘‘(ii) deny approval of the application

21 if the Secretary finds (and sets forth the

22 basis for such finding as part of or accom23 panying such denial) that one or more

24 grounds for denial specified in paragraph

25 (2) of this subsection apply.
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1 ‘‘(B) An order approving an application for

2 a tobacco product may require as a condition to

3 such approval that the sale and distribution of

4 the tobacco product be restricted but only to

5 the extent that the sale and distribution of a

6 tobacco product may be restricted under a regu7 lation under section 906(d).

8 ‘‘(2) DENIAL OF APPROVAL.—The Secretary

9 shall deny approval of an application for a tobacco

10 product if, upon the basis of the information sub11 mitted to the Secretary as part of the application

12 and any other information before the Secretary with

13 respect to such tobacco product, the Secretary finds

14 that—

15 ‘‘(A) there is a lack of a showing that per16 mitting such tobacco product to be marketed

17 would pose no greater risk to the public health

18 than currently marketed tobacco products;

19 ‘‘(B) the methods used in, or the facilities

20 or controls used for, the manufacture, proc21 essing, or packing of such tobacco product do

22 not conform to the requirements of section

23 906(e);
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1 ‘‘(C) based on a fair evaluation of all mate2 rial facts, the proposed labeling is false or mis3 leading in any particular; or

4 ‘‘(D) such tobacco product is not shown to

5 conform in all respects to a performance stand6 ard in effect under section 907, compliance with

7 which is a condition to approval of the applica8 tion, and there is a lack of adequate informa9 tion to justify the deviation from such standard.

10 ‘‘(3) DENIAL INFORMATION.—Any denial of an

11 application shall, insofar as the Secretary determines

12 to be practicable, be accompanied by a statement in13 forming the applicant of the measures required to

14 place such application in approvable form (which

15 measures may include further research by the appli16 cant in accordance with one or more protocols pre17 scribed by the Secretary).

18 ‘‘(4) BASIS FOR ACTION.—

19 ‘‘(A) For purposes of paragraph (2)(A),

20 whether permitting a tobacco product to be

21 marketed would be appropriate for the protec22 tion of the public health shall, when appro23 priate, be determined on the basis of well-con24 trolled investigations, which may include one or

25 more clinical investigations by experts qualified
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1 by training and experience to evaluate the to2 bacco product.

3 ‘‘(B) If the Secretary determines that

4 there exists valid scientific evidence (other than

5 evidence derived from investigations described

6 in subparagraph (A)) which is sufficient to

7 evaluate the tobacco product the Secretary may

8 authorize that the determination for purposes

9 of paragraph (2)(A) be made on the basis of

10 such evidence.

11 ‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—

12 ‘‘(1) IN GENERAL.—The Secretary shall, upon

13 obtaining, where appropriate, advice on scientific

14 matters from an advisory committee, and after due

15 notice and opportunity for informal hearing to the

16 holder of an approved application for a tobacco

17 product, issue an order withdrawing approval of the

18 application if the Secretary finds—

19 ‘‘(A) that the continued marketing of such

20 tobacco product poses greater risks to the pub21 lic health than other available products;

22 ‘‘(B) that the application contained or was

23 accompanied by an untrue statement of a mate24 rial fact;

25 ‘‘(C) that the applicant—
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1 ‘‘(i) has failed to establish a system

2 for maintaining records, or has repeatedly

3 or deliberately failed to maintain records

4 or to make reports, required by an applica5 ble regulation under section 909;

6 ‘‘(ii) has refused to permit access to,

7 or copying or verification of, such records

8 as required by section 704; or

9 ‘‘(iii) has not complied with the re10 quirements of section 905;

11 ‘‘(D) on the basis of new information be12 fore the Secretary with respect to such tobacco

13 product, evaluated together with the evidence

14 before the Secretary when the application was

15 approved, that the methods used in, or the fa16 cilities and controls used for, the manufacture,

17 processing, packing, or installation of such to18 bacco product do not conform with the require19 ments of section 906(e) and were not brought

20 into conformity with such requirements within a

21 reasonable time after receipt of written notice

22 from the Secretary of nonconformity;

23 ‘‘(E) on the basis of new information be24 fore the Secretary, evaluated together with the

25 evidence before the Secretary when the applica-
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1 tion was approved, that the labeling of such to2 bacco product, based on a fair evaluation of all

3 material facts, is false or misleading in any par4 ticular and was not corrected within a reason5 able time after receipt of written notice from

6 the Secretary of such fact; or

7 ‘‘(F) on the basis of new information be8 fore the Secretary, evaluated together with the

9 evidence before the Secretary when the applica10 tion was approved, that such tobacco product is

11 not shown to conform in all respects to a per12 formance standard which is in effect under sec13 tion 907, compliance with which was a condi14 tion to approval of the application, and that

15 there is a lack of adequate information to jus16 tify the deviation from such standard.

17 ‘‘(2) APPEAL.—The holder of an application

18 subject to an order issued under paragraph (1) with19 drawing approval of the application may, by petition

20 filed on or before the thirtieth day after the date

21 upon which he receives notice of such withdrawal,

22 obtain review thereof in accordance with subsection

23 (e) of this section.

24 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro25 viding an opportunity for an informal hearing, the
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1 Secretary determines there is reasonable probability

2 that the continuation of distribution of a tobacco

3 product under an approved application would cause

4 serious, adverse health consequences or death, that

5 is greater than ordinarily caused by tobacco prod6 ucts on the market, the Secretary shall by order

7 temporarily suspend the approval of the application

8 approved under this section. If the Secretary issues

9 such an order, the Secretary shall proceed expedi10 tiously under paragraph (1) to withdraw such appli11 cation.

12 ‘‘(e) SERVICE OF ORDER.—An order issued by the

13 Secretary under this section shall be served—

14 ‘‘(1) in person by any officer or employee of the

15 department designated by the Secretary; or

16 ‘‘(2) by mailing the order by registered mail or

17 certified mail addressed to the applicant at the ap18 plicant’s last known address in the records of the

19 Secretary.

20 ‘‘SEC. 911. JUDICIAL REVIEW.

21 ‘‘(a) IN GENERAL.—Not later than 30 days after—

22 ‘‘(1) the promulgation of a regulation under

23 section 907 establishing, amending, or revoking a

24 performance standard for a tobacco product; or
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1 ‘‘(2) a denial of an application for approval

2 under section 910(c),

3 any person adversely affected by such regulation or order

4 may file a petition with the United States Court of Ap5 peals for the District of Columbia or for the circuit where6 in such person resides or has his principal place of busi7 ness for judicial review of such regulation or order. A copy

8 of the petition shall be transmitted by the clerk of the

9 court to the Secretary or other officer designated by the

10 Secretary for that purpose. The Secretary shall file in the

11 court the record of the proceedings on which the Secretary

12 based the Secretary’s regulation or order and each record

13 or order shall contain a statement of the reasons for its

14 issuance and the basis, on the record, for its issuance. For

15 purposes of this section, the term ‘record’ means all no16 tices and other matter published in the Federal Register

17 with respect to the regulation or order reviewed, all infor18 mation submitted to the Secretary with respect to such

19 regulation or order, proceedings of any panel or advisory

20 committee with respect to such regulation or order, any

21 hearing held with respect to such regulation or order, and

22 any other information identified by the Secretary, in the

23 administrative proceeding held with respect to such regu24 lation or order, as being relevant to such regulation or

25 order.
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1 ‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD2 DITIONAL FINDINGS.—If the petitioner applies to the

3 court for leave to adduce additional data, views, or argu4 ments respecting the regulation or order being reviewed

5 and shows to the satisfaction of the court that such addi6 tional data, views, or arguments are material and that

7 there were reasonable grounds for the petitioner’s failure

8 to adduce such data, views, or arguments in the pro9 ceedings before the Secretary, the court may order the

10 Secretary to provide additional opportunity for the oral

11 presentation of data, views, or arguments and for written

12 submissions. The Secretary may modify the Secretary’s

13 findings, or make new findings by reason of the additional

14 data, views, or arguments so taken and shall file with the

15 court such modified or new findings, and the Secretary’s

16 recommendation, if any, for the modification or setting

17 aside of the regulation or order being reviewed, with the

18 return of such additional data, views, or arguments.

19 ‘‘(c) STANDARD OF REVIEW.—Upon the filing of the

20 petition under subsection (a) of this section for judicial

21 review of a regulation or order, the court shall have juris22 diction to review the regulation or order in accordance

23 with chapter 7 of title 5, United States Code, and to grant

24 appropriate relief, including interim relief, as provided in

25 such chapter. A regulation or order described in paragraph
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1 (1) or (2) of subsection (a) of this section shall not be

2 affirmed if it is found to be unsupported by substantial

3 evidence on the record taken as a whole.

4 ‘‘(d) FINALITY OF JUDGMENT.—The judgment of the

5 court affirming or setting aside, in whole or in part, any

6 regulation or order shall be final, subject to review by the

7 Supreme Court of the United States upon certiorari or

8 certification, as provided in section 1254 of title 28,

9 United States Code.

10 ‘‘(e) OTHER REMEDIES.—The remedies provided for

11 in this section shall be in addition to and not in lieu of

12 any other remedies provided by law.

13 ‘‘(f) REGULATIONS AND ORDERS MUST RECITE

14 BASIS IN RECORD.—To facilitate judicial review under

15 this section or under any other provision of law of a regu16 lation or order issued under section 906, 907, 908, 909,

17 910, or 913, each such regulation or order shall contain

18 a statement of the reasons for its issuance and the basis,

19 in the record of the proceedings held in connection with

20 its issuance, for its issuance.

21 ‘‘SEC. 912. REDUCED RISK TOBACCO PRODUCTS.

22 ‘‘(a) REQUIREMENTS.—

23 ‘‘(1) IN GENERAL.—For purposes of this sec24 tion, the term ‘reduced risk tobacco product’ means
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1 a tobacco product designated by the Secretary under

2 paragraph (2).

3 ‘‘(2) DESIGNATION.—

4 ‘‘(A) IN GENERAL.—A product may be

5 designated by the Secretary as a reduced risk

6 tobacco product if the Secretary finds that the

7 product is demonstrated to significantly reduce

8 harm to individuals caused by a tobacco prod9 uct and is otherwise appropriate to protect pub10 lic health, based on an application submitted by

11 the manufacturer of the product (or other re12 sponsible person) that—

13 ‘‘(i)(I) demonstrates through testing

14 on animals and short-term human testing

15 that use of such product results in inges16 tion or inhalation of a substantially lower

17 yield of toxic substances than use of an18 other tobacco product in the same or dif19 ferent category as the proposed reduced

20 risk product; or

21 ‘‘(II) contains scientific evidence

22 showing that use of such product results in

23 a substantially lower potential risk to

24 health in one or more specific respects

25 than use of another tobacco product in the
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1 same or different category as the proposed

2 reduced risk product; and

3 ‘‘(ii) if required by the Secretary, in4 cludes studies of the long-term health ef5 fects of the product.

6 If such studies are required, the manufacturer

7 may consult with the Secretary regarding proto8 cols for conducting the studies.

9 ‘‘(B) BASIS FOR FINDING.—In making the

10 finding under subparagraph (A), the Secretary

11 shall take into account—

12 ‘‘(i) the risks and benefits to the pop13 ulation as a whole, including both users of

14 tobacco products and non-users of tobacco

15 products;

16 ‘‘(ii) the increased or decreased likeli17 hood that existing users of tobacco prod18 ucts will stop using such products includ19 ing reduced risk tobacco products;

20 ‘‘(iii) the increased or decreased likeli21 hood that those who do not use tobacco

22 products will start to use such products,

23 including reduced risk tobacco products;

24 and
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1 ‘‘(iv) the risks and benefits to con2 sumers from the use of a reduced risk to3 bacco product as compared to the use of

4 products approved under chapter V to re5 duce exposure to tobacco.

6 ‘‘(3) MARKETING REQUIREMENTS.—A tobacco

7 product may be marketed and labeled as a reduced

8 risk tobacco product if it—

9 ‘‘(A) has been designated as a reduced risk

10 tobacco product by the Secretary under para11 graph (2);

12 ‘‘(B) bears a label prescribed by the Sec13 retary concerning the product’s contribution to

14 reducing harm to health; and

15 ‘‘(C) complies with requirements prescribed

16 by the Secretary relating to marketing and ad17 vertising of the product, and other provisions of

18 this chapter as prescribed by the Secretary, al19 though in no event shall such requirements pro20 hibit the communication that such product is a

21 reduced risk product. The communication that

22 such product is a reduced risk product may

23 comply with requirements prescribed by the

24 Secretary relating to such communication, and
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1 the Secretary may require prior approval of the

2 communication.

3 ‘‘(b) REVOCATION OF DESIGNATION.—At any time

4 after the date on which a tobacco product is designated

5 as a reduced risk tobacco product under this section the

6 Secretary may, after providing an opportunity for an in7 formal hearing, revoke such designation if the Secretary

8 determines, based on information not available at the time

9 of the designation, that—

10 ‘‘(1) the finding made under subsection (a)(2)

11 is no longer valid; or

12 ‘‘(2) the product is being marketed in violation

13 of subsection (a)(3).

14 ‘‘(c) LIMITATION.—A tobacco product that is des15 ignated as a reduced risk tobacco product that is in com16 pliance with subsection (a) shall not be regulated as a

17 drug or device.

18 ‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO

19 PRODUCT TECHNOLOGY.—A tobacco product manufac20 turer shall provide written notice to the Secretary upon

21 the development or acquisition by the manufacturer of any

22 technology that would reduce the risk of a tobacco product

23 to the health of the user for which the manufacturer is

24 not seeking designation as a ‘reduced risk tobacco product’

25 under subsection (a).
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1 ‘‘(e) POSTMARKET SURVEILLANCE.—

2 ‘‘(1) DISCRETIONARY SURVEILLANCE.—The

3 Secretary may require a tobacco product manufac4 turer to conduct postmarket surveillance for reduced

5 risk a tobacco product of the manufacturer if the

6 Secretary determines that postmarket surveillance of

7 the tobacco product is necessary to protect the pub8 lic health or is necessary to provide information re9 garding the health risks and other safety issues in10 volving the tobacco product.

11 ‘‘(2) SURVEILLANCE APPROVAL.—Each tobacco

12 product manufacturer required to conduct a surveil13 lance of a reduced risk tobacco product under para14 graph (1) shall, within 30 days after receiving notice

15 that the manufacturer is required to conduct such

16 surveillance, submit, for the approval of the Sec17 retary, a protocol for the required surveillance. The

18 Secretary, within 60 days of the receipt of such pro19 tocol, shall determine if the principal investigator

20 proposed to be used in the surveillance has sufficient

21 qualifications and experience to conduct such sur22 veillance and if such protocol will result in collection

23 of useful data or other information necessary to pro24 tect the public health. The Secretary may not ap25 prove such a protocol until it has been reviewed by
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1 an appropriately qualified scientific and technical re2 view committee established by the Secretary.

3 ‘‘SEC. 913. PRESERVATION OF STATE AND LOCAL AUTHOR4 ITY.

5 ‘‘(a) ADDITIONAL REQUIREMENTS.—

6 ‘‘(1) IN GENERAL.—Except as provided in para7 graph (2), nothing in this Act shall be construed as

8 prohibiting a State or political subdivision thereof

9 from adopting or enforcing a requirement applicable

10 to a tobacco product that is in addition to, or more

11 stringent than, requirements established under this

12 chapter.

13 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

14 LOCAL REQUIREMENTS.—

15 ‘‘(A) Except as provided in subparagraph

16 (B), no State or political subdivision of a State

17 may establish or continue in effect with respect

18 to a tobacco product any requirement which is

19 different from, or in addition to, any require20 ment applicable under the provisions of this

21 chapter relating to performance standards, pre22 market approval, adulteration, misbranding,

23 registration, labeling, good manufacturing

24 standards, or reduced risk products.
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1 ‘‘(B) Subparagraph (A) does not apply to

2 requirements relating to the sale, use, or dis3 tribution of a tobacco product including require4 ments related to the access to, and the adver5 tising and promotion of, a tobacco product.

6 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

7 LIABILITY.—No provision of this chapter relating to a to8 bacco product shall be construed to modify or otherwise

9 affect any action or the liability of any person under the

10 product liability law of any State.

11 ‘‘SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS.

12 ‘‘The Secretary shall issue regulations to require that

13 retail establishments for which the predominant business

14 is the sale of tobacco products comply with any advertising

15 restrictions applicable to retail establishments accessible

16 to individuals under the age of 18.

17 ‘‘SEC. 915. ACCESS AND MARKETING RESTRICTIONS.

18 ‘‘(a) DEFINITIONS.—For purposes of this section, the

19 following definitions apply:

20 ‘‘(1) ADULT.—The term ‘adult’ means any per21 son who is older than the minimum age at which it

22 is legal to purchase or possess (whichever minimum

23 age is older) tobacco products.

24 ‘‘(2) ADULT-ONLY FACILITY.—The term ‘adult25 only facility’ means a facility or restricted area
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1 (whether open-air or enclosed) where the operator

2 ensures or has a reasonable basis to believe (such as

3 by checking identification as required under state

4 law, or by checking the identification of any person

5 appearing to be under the age of 27) that only

6 adults are present. A facility or restricted area need

7 not be permanently restricted to adults in order to

8 constitute an adult-only facility, provided that the

9 operator ensures or has a reasonable basis to believe

10 that only adults are present during the event or time

11 period in question.

12 ‘‘(3) BRAND NAME.—The term ‘brand name’

13 means a brand name (alone or in conjunction with

14 any other word), trademark, logo, symbol, motto,

15 selling message, recognizable pattern of colors, or

16 any other indicia of product identification identical

17 or similar to, or identifiable with, those used for any

18 domestic brand of tobacco products. The term

19 ’brand name’ shall not include the corporate name

20 of any tobacco product manufacturer that does not

21 after the date of the enactment of this Act sell a

22 brand of tobacco products in the United States that

23 includes such corporate name.

24 ‘‘(b) CIGARETTE AND SMOKELESS TOBACCO PROD25 UCT REQUIREMENTS.—
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1 ‘‘(1) MINIMUM SALES AGE.—No retailer may

2 sell a tobacco product to any person younger than

3 18 years of age.

4 ‘‘(2) PROOF OF AGE.—

5 ‘‘(A) Except as otherwise provided in sub6 paragraph (B), each retailer shall verify by

7 means of photographic identification containing

8 the bearer’s date of birth that no person pur9 chasing the product is younger than 18 years of

10 age.

11 ‘‘(B) No such verification is required for

12 any person over the age of 26.

13 ‘‘(3) ENFORCEMENT BY THE STATES.—The

14 Secretary may enter into an agreement with any

15 State which has in effect a State law that is at least

16 as restrictive as this subsection, whereby such State

17 agrees to enforce such State law in a manner rea18 sonably designed to prevent its violation and the

19 Secretary provides a grant to such State for the pur20 pose of enforcing such State law. No action taken by

21 the Secretary pursuant to this paragraph shall be

22 construed to limit the authority of the Secretary

23 under this subsection.

24 ‘‘(4) MAIL ORDER SALES.—After two years

25 from the date of enactment of this Act, the Sec-
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1 retary shall transmit to Congress a report describing

2 the extent, if any, to which individuals younger than

3 18 years of age are obtaining tobacco products

4 through the mail.

5 ‘‘(c) MINIMUM PACKAGE SIZE REQUIREMENTS.—

6 ‘‘(1) No manufacturer, distributor, or retailer

7 may sell or cause to be sold, or distribute or cause

8 to be distributed, any cigarette package that con9 tains fewer than 20 cigarettes.

10 ‘‘(2) No retailer may break or otherwise open

11 any tobacco product package to sell or distribute in12 dividual cigarettes or a number of unpackaged ciga13 rettes that is smaller than the quantity in the min14 imum cigarette package size provided in paragraph

15 (1), or any quantity of another tobacco product that

16 is smaller than the smallest package distributed by

17 the manufacturer for individual consumer use.

18 ‘‘(d) BAN ON YOUTH ACCESS TO FREE SAMPLES.—

19 ‘‘(1) No manufacturer, distributor, or retailer

20 may distribute or cause to be distributed any free

21 samples of tobacco products, except in an adult-only

22 facility.

23 ‘‘(2) For purposes of this subsection, a ‘free

24 sample’ does not include a tobacco product that is

25 provided to an adult in connection with—
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1 ‘‘(A) the purchase, exchange or redemption

2 for proof of purchase of any tobacco products

3 (including, but not limited to, a free offer in

4 connection with the purchase of tobacco prod5 ucts, such as a ‘two-for-one’ offer), or

6 ‘‘(B) the conducting of consumer testing or

7 evaluation of tobacco products with persons who

8 certify that they are adults.

9 ‘‘(e) VENDING MACHINES, SELF-SERVICE DISPLAYS,

10 MAIL-ORDER SALES, AND OTHER ‘IMPERSONAL’ MODES

11 OF SALE.—

12 ‘‘(1) Except as otherwise provided in paragraph

13 (2), a retailer may sell a tobacco product only in a

14 direct, face-to-face exchange between the retailer and

15 the consumer. Examples of methods of sale that are

16 not permitted include vending machines and self17 service displays.

18 ‘‘(2) The following methods of sale are per19 mitted under this subsection:

20 ‘‘(A) Mail-order sales, excluding mail-order

21 redemption of coupons and distribution of free

22 samples through the mail.

23 ‘‘(B) Vending machines that are located in

24 an adult-only facility.
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1 ‘‘(3) For purposes of this section, a ‘self-serv2 ice’ display means any display where the customer

3 has access to the tobacco products without the aid

4 of a sales clerk.

5 ‘‘(f) PROHIBITION ON YOUTH TARGETING.—No

6 manufacturer, distributor, or retailer may take any action,

7 directly or indirectly, to target youth in the advertising,

8 promotion, or marketing of tobacco products, or take any

9 action the primary purpose of which is to initiate, main10 tain, or increase the incidence of youth smoking. For pur11 poses of this subsection, the term ‘youth’ means any per12 son or persons under 18 years of age.

13 ‘‘(g) BAN ON USE OF CARTOONS.—

14 ‘‘(1) No manufacturer, distributor, or retailer

15 may use or cause to be used any cartoon in the ad16 vertising, promoting, packaging, or labeling of to17 bacco products.

18 ‘‘(2) For purposes of this subsection, the term

19 ‘cartoon’ means any drawing or other depiction of

20 an object, person, animal, creature, or any similar

21 caricature that satisfies any of the following criteria:

22 ‘‘(A) The use of comically exaggerated fea23 tures;
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1 ‘‘(B) The attribution of human character2 istics to animals, plants, or other objects, or the

3 similar use of anthropomorphic technique.

4 ‘‘(C) The attribution of unnatural or

5 extrahuman abilities, such as imperviousness to

6 pain or injury, X-ray vision, tunneling at very

7 high speeds, or transformation.

8 ‘‘(3) The term ‘cartoon’ includes ‘Joe Camel,’

9 but does not include any drawing or other depiction

10 that, on July 1, 1998, was in use in the United

11 States in any manufacturer’s corporate logo or in

12 any manufacturer’s tobacco product packaging.

13 ‘‘(h) ELIMINATION OF OUTDOOR ADVERTISING.—

14 ‘‘(1) No manufacturer, distributor, or retailer

15 may place or cause to be placed any outdoor adver16 tising advertising tobacco products.

17 ‘‘(2) For purposes of this subsection, the term

18 ‘outdoor advertising’ means—

19 ‘‘(A) billboards;

20 ‘‘(B) signs and placards in arenas, sta21 diums, shopping malls, and video game arcades

22 (whether any of the foregoing are open air or

23 enclosed); and

24 ‘‘(C) any other advertisements placed—

25 ‘‘(i) outdoors, or
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1 ‘‘(ii) on the inside surface of a window

2 facing outward.

3 ‘‘(D) The term ‘outdoor advertising’ does

4 not mean—

5 ‘‘(i) an advertisement on the outside

6 of a tobacco product manufacturing facil7 ity;

8 ‘‘(ii) an individual advertisement that

9 does not occupy an area larger than 14

10 square feet (and that neither is placed in

11 such proximity to any other such advertise12 ment so as to create a single ‘mosaic’-type

13 advertisement larger than 14 square feet,

14 nor functions solely as a segment of a larg15 er advertising unit or series), and that is

16 placed on the outside of any retail estab17 lishment that sells tobacco products (other

18 than solely through a vending machine), on

19 the outside (but on the property of) any

20 such establishment, or on the inside sur21 face of a window facing outward in any

22 such establishment; or

23 ‘‘(iii) an advertisement inside a retail

24 establishment that sells tobacco products

25 (other than solely through a vending ma-
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1 chine) that is not placed on the inside sur2 face of a window facing outward.

3 ‘‘(3) For purposes of this subsection, the term

4 ‘video game arcade’ means an entertainment estab5 lishment primarily consisting of video games (other

6 than video games intended primarily for use by per7 sons 18 years of age or older) and/or pinball ma8 chines.

9 ‘‘(i) ELIMINATION OF TRANSIT ADVERTISEMENTS.—

10 ‘‘(1) No manufacturer, distributor, or retailer

11 may place or cause to be placed any transit adver12 tisements advertising tobacco products.

13 ‘‘(2) For purposes of this subsection, the term

14 ‘transit advertisements’ means advertising on or

15 within private or public vehicles and all advertise16 ments placed at, on or within any bus stop, taxi

17 stand, transportation waiting area, train station, air18 port, or any similar location.

19 ‘‘(3) The term ‘transit advertisements’ does not

20 include any advertisement placed in, on, or outside

21 the premises of any retail establishment that sells

22 tobacco products (other than solely through a vend23 ing machine), except if such individual

24 advertisement—
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1 ‘‘(A) occupies an area larger than 14

2 square feet;

3 ‘‘(B) is placed in such proximity to any

4 other such advertisement so as to create a sin5 gle ‘mosaic’-type advertisement larger than 14

6 square feet; or

7 ‘‘(C) functions solely as a segment of a

8 larger advertising unit or series).

9 ‘‘(j) BAR ON ADVERTISING IN ANY YOUTH-ORI10 ENTED PUBLICATION.—

11 ‘‘(1) No manufacturer, distributor, or retailer

12 shall advertise a tobacco product in any youth-ori13 ented publication (whether periodic or limited dis14 tribution).

15 ‘‘(2) For purposes of this subsection, a ‘youth

16 oriented publication’ is a newspaper, magazine, peri17 odical, or other publication—

18 ‘‘(A) whose readers younger than 18 years

19 of age constitute more than 15 percent of the

20 total readership as measured by competent and

21 reliable survey evidence; or

22 ‘‘(B) that is read by 2,000,000 or more

23 persons younger than 18 years of age as meas24 ured by competent and reliable survey evidence.
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1 ‘‘(k) BAN ON TOBACCO PRODUCT BRAND NAME

2 SPONSORSHIPS.—

3 ‘‘(1) No manufacturer, distributor, or retailer

4 may sponsor or cause to be sponsored any athletic,

5 musical, artistic, or other social or cultural event, or

6 any entry or team in any event, in the brand name

7 (alone or in conjunction with any other word), logo,

8 symbol, motto, selling message, recognizable color or

9 pattern of colors, or any other indicia of product

10 identification identical or similar to, or identifiable

11 with, those used for any brand of cigarettes or

12 smokeless tobacco.

13 ‘‘(2) Nothing in this subsection shall be con14 strued to prevent a manufacturer, distributor, or re15 tailer from sponsoring or causing to be sponsored

16 any athletic, musical, artistic, or other social or cul17 tural event, or team or entry, in the name of the

18 corporation which manufactures the tobacco product,

19 provided that both the corporate name and the cor20 poration were registered and in use in the United

21 States prior to January 1, 2001, and that the cor22 porate name does not include any brand name (alone

23 or in conjunction with any other word), logo, symbol,

24 motto, selling message, recognizable color or pattern

25 of colors, or any other indicia of product identifica-
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1 tion identical or similar to, or identifiable with, those

2 used for any brand of cigarettes or smokeless to3 bacco.

4 ‘‘(3) This subsection shall not apply to any

5 event sponsored in an adult-only facility.

6 ‘‘(l) BAN ON TOBACCO BRAND NAME MERCHAN7 DISE.—

8 ‘‘(1) No manufacturer may market, distribute,

9 offer, sell, license or cause to be marketed, distrib10 uted, offered, sold, or licensed (including, without

11 limitation, by catalogue or direct mail), any apparel

12 or other merchandise (other than tobacco products,

13 items the sole function of which is to advertise to14 bacco products, or written or electronic publications)

15 which bears a brand name.

16 ‘‘(2) Nothing in this subsection shall—

17 ‘‘(A) prohibit the distribution to any man18 ufacturer’s employee who is an adult of any

19 item described above that is intended for the

20 personal use of such an employee;

21 ‘‘(B) require any manufacturer to retrieve,

22 collect or otherwise recover any item that prior

23 to the enactment of this Act was marketed, dis24 tributed, offered, sold, licensed, or caused to be
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1 marketed, distributed, offered, sold, or licensed

2 by such manufacturer;

3 ‘‘(C) apply to coupons or other items used

4 by adults solely in connection with the purchase

5 of tobacco products; or

6 ‘‘(D) apply to apparel or other merchan7 dise used within an adult-only facility that is

8 not distributed (by sale or otherwise) to any

9 member of the general public.

10 ‘‘(m) BAN ON GIFTS TO UNDERAGE PERSONS BASED

11 ON PROOFS OF PURCHASE.—

12 ‘‘(1) No manufacturer, distributor, or retailer

13 may provide or cause to be provided to any person,

14 without sufficient proof that such person is an adult,

15 any item in exchange for the purchase of tobacco

16 products, or the furnishing of credits, proofs-of-pur17 chase, or coupons with respect to such a purchase.

18 ‘‘(2)(A) For purposes of paragraph (1), a driv19 er’s license or other government-issued identification

20 (or legible photocopy thereof), the validity of which

21 is certified by the person to whom the item is pro22 vided, shall by itself be deemed to be a sufficient

23 form of proof of age; and

24 ‘‘(B) In the case of items provided (or to be re25 deemed) at retail establishments, a manufacturer
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1 shall be entitled to rely on verification of proof of

2 age by the retailer, where such retailer is required

3 to obtain verification under applicable Federal, State

4 or local law.

5 ‘‘(n) BAN ON NON-TOBACCO PRODUCT BRAND

6 NAMES.—

7 ‘‘(1) Except as provided in paragraph (2), no

8 manufacturer may, pursuant to any agreement re9 quiring the payment of money or other valuable con10 sideration, use or cause to be used as a brand name

11 of any tobacco product any nationally recognized or

12 nationally established brand name or trade name of

13 any non-tobacco item or service or any nationally

14 recognized or nationally established sports team, en15 tertainment group, or individual celebrity.

16 ‘‘(2) Paragraph (1) shall not apply to any to17 bacco product brand name in existence as of July 1,

18 1998.

19 ‘‘(3) For the purposes of this section, the term

20 ‘other valuable consideration’ shall not include an

21 agreement between two entities who enter into such

22 agreement for the sole purpose of avoiding infringe23 ment claims.

24 ‘‘(o) LIMITATION ON THIRD PARTY USE OF TO25 BACCO BRAND NAMES.—
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1 ‘‘(1) No manufacturer may license or otherwise

2 expressly authorize any third party to use or adver3 tise any brand name in a manner prohibited by this

4 Act if done by such manufacturer itself.

5 ‘‘(2) Nothing in this subsection shall require

6 any manufacturer to retrieve, collect, or otherwise

7 recover any item that prior to the enactment of this

8 Act was marketed, distributed, offered, sold, li9 censed, or caused to be marketed, distributed, of10 fered, sold, or licensed by such manufacturer.

11 ‘‘(p) BAR ON PRODUCT PLACEMENT IN CERTAIN

12 MEDIA.—

13 ‘‘(1) Except as provided in paragraph (2), no

14 manufacturer may make, or cause to be made, any

15 payment or other consideration to any other person

16 or entity to use, display, make reference to, or use

17 as a prop any tobacco product, tobacco product

18 package, advertisement for a tobacco product, or any

19 other item bearing a brand name in any motion pic20 ture, television show, theatrical production or other

21 live performance, live or recorded performance of

22 music, commercial film or video, or video game

23 (‘media’).

24 ‘‘(2) Paragraph (1) shall not apply to—
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1 ‘‘(A) media where the audience or viewers

2 are within an adult-only facility (provided such

3 media are not visible to persons outside such

4 adult-only facility);

5 ‘‘(B) media not intended for distribution or

6 display to the public; or

7 ‘‘(C) instructional media concerning non8 conventional tobacco products or tobacco prod9 ucts designated as reduced risk viewed only by

10 or provided only to consumers who are adults.

11 ‘‘(q) SEVERABILITY.—If any provision of this section

12 is held invalid, those subsections, and paragraphs which

13 are not so held shall continue to be in effect.

14 ‘‘(r) EFFECTIVE DATES.—The provisions of this sec15 tion shall take effect on the date that is six months after

16 the date of enactment of this section, except for the provi17 sions of subsections (e) and (k), which shall take effect

18 on the date that is one year after the effective date of

19 this section.

20 ‘‘SEC. 916. MANDATORY DISCLOSURES.

21 ‘‘(a) DISCLOSURE OF INGREDIENTS TO THE PUB22 LIC.—

23 ‘‘(1) Not later than 12 months after the effec24 tive date of this section, the Secretary shall promul25 gate regulations requiring the disclosure to the pub-
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1 lic on a brand-by-brand basis of the common or

2 usual name of each ingredient of a tobacco product

3 in descending order of predominance by weight, ex4 cept that spices, flavorings, and colorings may at the

5 manufacturer’s election be designated as spices,

6 flavorings, and colorings without naming each. Any

7 ingredient that has been disclosed to the public pur8 suant to any other law or regulation with respect to

9 a particular brand may be required to be disclosed

10 for such brand pursuant to this subsection.

11 ‘‘(2) The regulations required by this subsection

12 shall provide that incidental additives that are

13 present in a tobacco product at insignificant levels

14 and that do not have any technical or functional ef15 fect in the finished tobacco product shall be exempt

16 from disclosure.

17 ‘‘(3) The requirement of this subsection to dis18 close ingredients in descending order of predomi19 nance shall not apply to ingredients in amounts of

20 2 percent or less by weight when a listing of such

21 ingredients is placed at the end of the ingredients

22 statement following an appropriate quantifying

23 statement, such as ‘contains ll percent or less of

24 ll’, or ‘less than ll percent of ll’.
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1 ‘‘(4) Any disclosure required pursuant to this

2 subsection may be required by appropriate means,

3 except that, notwithstanding any other provision of

4 this act, the Secretary shall not require the listing

5 of any ingredient on any package or in any adver6 tisement.

7 ‘‘(b) DISCLOSURE OF PERCENTAGE OF DOMESTIC

8 AND FOREIGN TOBACCO.—Not later than 12 months after

9 the effective date of this section, the Secretary shall pro10 mulgate regulations that require that each package of a

11 tobacco product disclose, with respect to the tobacco con12 tained in that brand—

13 ‘‘(1) the percentage of tobacco that is domestic

14 tobacco; and

15 ‘‘(2) the percentage of tobacco that is foreign

16 tobacco.

17 ‘‘(c) MANDATORY DISCLAIMER.—

18 ‘‘(1) Any tobacco product advertising which in19 cludes a term classifying a brand of tobacco product

20 according to its ‘tar’ yield or the yield to consumers

21 of any substance, including but not limited to terms

22 such as ‘light’, or ‘low tar’, shall also include the fol23 lowing disclaimer: ‘[Brand] not shown to be less

24 hazardous than other [type of tobacco product]’.

25 This section shall not be deemed to apply to the use
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1 of the terms ‘filtered’ or ‘filter’. In no event shall

2 any such disclaimer be required on any tobacco

3 product package.

4 ‘‘(2) In addition to the provisions of paragraph

5 (1), not later than 12 months after the effective date

6 of this section, the Secretary shall promulgate regu7 lations relating to the use of such terms, to ensure

8 that they are not false or misleading.

9 ‘‘(3) The Secretary may modify or waive any

10 requirement under this subsection with respect to

11 any product that has been designated by the Sec12 retary as a reduced risk product under section

13 912.’’.

14 SEC. 5. REGULATORY RECORD.

15 Notwithstanding the provisions of subchapter II of

16 chapter 5 of title 5, United States Code, in promulgating

17 regulations under this chapter, the record developed and

18 utilized by the Secretary for the purposes of promulgating

19 subparts (B) and (D) of the regulations relating to the

20 sale, distribution, and use of tobacco products on or about

21 August 28, 1996, as reflected in articles IV and VI of the

22 preamble to the 1996 Food and Drug Administration To23 bacco Rule (including public comments, Food and Drug

24 Administration documents, and any other information

25 generated or compiled for purposes of promulgating such
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1 regulations), shall be deemed to have the same legal status

2 as if such record had been developed under a rulemaking

3 proceeding conducted pursuant to section 906(d)(1). In all

4 other respects, including with respect to the issue of

5 whether such regulations conform to section 906(d)(1),

6 the procedural requirements of this chapter and the Ad7 ministration Procedure Act will apply.

8 SEC. 6. CONFORMING AND OTHER AMENDMENTS TO GEN9 ERAL PROVISIONS.

10 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

11 COSMETIC ACT.—Except as otherwise expressly provided,

12 whenever in this section an amendment is expressed in

13 terms of an amendment to, or repeal of, a section or other

14 provision, the reference is to a section or other provision

15 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

16 301 et seq.).

17 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is

18 amended—

19 (1) in subsection (a), by inserting ‘‘tobacco

20 product,’’ after ‘‘device,’’;

21 (2) in subsection (b), by inserting ‘‘tobacco

22 product,’’ after ‘‘device,’’;

23 (3) in subsection (c), by inserting ‘‘tobacco

24 product,’’ after ‘‘device,’’;
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1 (4) in subsection (e), by striking ‘‘515(f), or

2 519’’ and inserting ‘‘515(f), 519, or 909’’;

3 (5) in subsection (g), by inserting ‘‘tobacco

4 product,’’ after ‘‘device,’’;

5 (6) in subsection (h), by inserting ‘‘tobacco

6 product,’’ after ‘‘device,’’;

7 (7) in subsection (j), by striking ‘‘708, or 721’’

8 and inserting ‘‘708, 721, 903, 904, 905, 906, 907,

9 908, 909, 910, or 912’’;

10 (8) in subsection (k), by inserting ‘‘tobacco

11 product,’’ after ‘‘device,’’;

12 (9) by striking subsection (p) and inserting the

13 following:

14 ‘‘(p) The failure to register in accordance with section

15 510 or 905, the failure to provide any information re16 quired by section 510(j), 510(k), 905(i), or 905(j), or the

17 failure to provide a notice required by section 510(j)(2)

18 or 905(j)(2).’’;

19 (10) in subsection (q), by striking paragraph

20 (1) and inserting the following:

21 ‘‘(1) The failure or refusal—

22 ‘‘(A) to comply with any requirement prescribed

23 under section 518, 520(g), 906(f), or 908;
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1 ‘‘(B) to furnish any notification or other mate2 rial or information required by or under section 519,

3 520(g), 904, 906(f), or 909; or

4 ‘‘(C) to comply with a requirement under sec5 tion 522.’’;

6 (11) in subsection (q)(2), by striking ‘‘device,’’

7 and inserting ‘‘device or tobacco product,’’;

8 (12) in subsection (r), by inserting ‘‘or tobacco

9 product’’ after ‘‘device’’ each time that it appears;

10 and

11 (13) by adding at the end the following:

12 ‘‘(aa) The sale of tobacco products in violation

13 of a no-tobacco-sale order issued under section

14 303(f).’’.

15 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f))

16 is amended—

17 (1) by striking the subsection heading and in18 serting the following:

19 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR20 DERS.—’’;

21 (2) in paragraph (1)(A), by inserting ‘‘or to22 bacco products’’ after ‘‘devices’’;

23 (3) by redesignating paragraphs (3), (4), and

24 (5) as paragraphs (4), (5), and (6), respectively;
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1 (4) by inserting after paragraph (2) the fol2 lowing:

3 ‘‘(3) If the Secretary finds that a person has

4 committed repeated violations of restrictions promul5 gated under section 906(d) at a particular retail out6 let then the Secretary may impose a no-tobacco-sale

7 order on that person prohibiting the sale of tobacco

8 products in that outlet. A no-tobacco-sale order may

9 be imposed with a civil penalty under paragraph

10 (1).’’;

11 (5) in subparagraph (A) of paragraph (4), as so

12 redesignated—

13 (A) by striking ‘‘assessed’’ the first time it

14 appears and inserting ‘‘assessed, or a no-to15 bacco-sale order may be imposed,’’; and

16 (B) by striking ‘‘penalty’’ and inserting

17 ‘‘penalty, or upon whom a no-tobacco-order is

18 to be imposed,’’;

19 (6) in subparagraph (B) of paragraph (4), as so

20 redesignated—

21 (A) by inserting after ‘‘penalty,’’ the fol22 lowing: ‘‘or the period to be covered by a no-to23 bacco-sale order,’’; and

24 (B) by adding at the end the following: ‘‘A

25 no-tobacco-sale order permanently prohibiting
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1 an individual retail outlet from selling tobacco

2 products shall include provisions that allow the

3 outlet, after a specified period of time, to re4 quest that the Secretary compromise, modify,

5 or terminate the order.’’;

6 (7) by adding at the end of paragraph (4), as

7 so redesignated, the following:

8 ‘‘(D) The Secretary may compromise, mod9 ify, or terminate, with or without conditions,

10 any no-tobacco-sale order.’’;

11 (8) in paragraph (5), as so redesignated—

12 (A) by striking ‘‘(3)(A)’’ and inserting

13 ‘‘(4)(A)’’;

14 (B) by inserting ‘‘or the imposition of a

15 no-tobacco-sale order’’ after ‘‘penalty’’ the first

16 2 places it appears;

17 (C) by striking ‘‘issued.’’ and inserting

18 ‘‘issued, or on which the no-tobacco-sale order

19 was imposed, as the case may be.’’; and

20 (9) in paragraph (6), as so redesignated, by

21 striking ‘‘paragraph (4)’’ each place it appears and

22 inserting ‘‘paragraph (5)’’.

23 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is

24 amended—
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1 (1) in subsection (a)(2), by striking ‘‘and’’ be2 fore ‘‘(D)’’;

3 (2) in subsection (a)(2), by striking ‘‘device.’’

4 and inserting a comma and the following:

5 ‘‘(E) Any adulterated or misbranded to6 bacco product.’’;

7 (3) in subsection (d)(1), by inserting ‘‘tobacco

8 product,’’ after ‘‘device,’’;

9 (4) in subsection (g)(1), by inserting ‘‘or to10 bacco product’’ after ‘‘device’’ each place it appears;

11 and

12 (5) in subsection (g)(2)(A), by inserting ‘‘or to13 bacco product’’ after ‘‘device’’ each place it appears.

14 (e) SECTION 702.—Section 702(a) (21 U.S.C.

15 372(a)) is amended—

16 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and

17 (2) by adding at the end thereof the following:

18 ‘‘(2) For a tobacco product, to the extent feasible,

19 the Secretary shall contract with the States in accordance

20 with paragraph (1) to carry out inspections of retailers

21 in connection with the enforcement of this Act.’’.

22 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is

23 amended—

24 (1) by inserting ‘‘tobacco product,’’ after ‘‘de25 vice,’’ each place it appears; and
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1 (2) by inserting ‘‘tobacco products,’’ after ‘‘de2 vices,’’ each place it appears.

3 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is

4 amended—

5 (1) in subsection (a)(1)(A), by inserting ‘‘to6 bacco products,’’ after ‘‘devices,’’ each place it ap7 pears;

8 (2) in subsection (a)(1)(B), by inserting ‘‘or to9 bacco products’’ after ‘‘restricted devices’’ each place

10 it appears; and

11 (3) in subsection (b), by inserting ‘‘tobacco

12 product,’’ after ‘‘device,’’.

13 (h) SECTION 705.—Section 705(b) (21 U.S.C.

14 375(b)) is amended by inserting ‘‘tobacco products,’’ after

15 ‘‘devices,’’.

16 (i) SECTION 709.—Section 709 (21 U.S. C. 379) is

17 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’.

18 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is

19 amended—

20 (1) in subsection (a), by inserting ‘‘tobacco

21 products,’’ after ‘‘devices,’’ the first time it appears;

22 (2) in subsection (a), by inserting ‘‘or sub23 section (j) of section 905’’ after ‘‘section 510’’;
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1 (3) in subsection (a), by striking ‘‘drugs or de2 vices’’ each time it appears and inserting ‘‘drugs, de3 vices, or tobacco products’’; and

4 (4) in subsection (e)(1), by inserting ’tobacco

5 product’ after ’device’.

6 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re7 designated by section 101(a)) is amended—

8 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and

9 (2) inserting a comma and ‘‘and tobacco prod10 ucts’’ after ‘‘devices’’.

11 (l) EFFECTIVE DATE FOR NO-TOBACCO-SALE

12 ORDER AMENDMENTS.—The amendments made by sub13 section (c), other than the amendment made by paragraph

14 (2) thereof, shall take effect only upon the promulgation

15 of final regulations by the Secretary—

16 (1) defining the term ‘‘repeated violation’’, as

17 used in section 303(f) of the Federal Food, Drug,

18 and Cosmetic Act (21 U.S.C. 333(f)) as amended by

19 subsection (c), by identifying the number of viola20 tions of particular requirements over a specified pe21 riod of time that constitute a repeated violation;

22 (2) providing for notice to the retailer of each

23 violation at a particular retail outlet;

24 (3) providing that a person may not be charged

25 with repeated violations at a particular retail outlet
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1 unless the Secretary has provided notice of previous

2 violations at that outlet;

3 (4) establishing a period of time during which,

4 if there are no violations by a particular retail out5 let, that outlet will not be considered to have been

6 the site of repeated violations when the next viola7 tion occurs; and

8 (5) providing that good faith reliance on false

9 identification does not constitute a violation of any

10 minimum age requirement for the sale of tobacco

11 products.

12 SEC. 7. CIGARETTE LABEL AND ADVERTISING WARNINGS.

13 Section 4 of the Federal Cigarette Labeling and Ad14 vertising Act (15 U.S.C. 1333) is amended to read as fol15 lows:

16 ‘‘SEC. 4. LABELING.

17 ‘‘(a) LABEL REQUIREMENTS.—

18 ‘‘(1) IN GENERAL.—It shall be unlawful for any

19 person to manufacture, package, or import for sale

20 or distribution within the United States any ciga21 rettes the package of which fails to bear, in accord22 ance with the requirements of this section, one of

23 the following labels:

24 ‘‘WARNING: Cigarettes are addictive’’
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1 ‘‘WARNING: Tobacco smoke can harm your chil2 dren’’

3 ‘‘WARNING: Cigarettes cause fatal lung disease’’

4 ‘‘WARNING: Cigarettes cause cancer’’

5 ‘‘WARNING: Cigarettes cause strokes and heart

6 disease’’

7 ‘‘WARNING: Smoking during pregnancy can harm

8 your baby’’

9 ‘‘WARNING: Smoking can kill you’’

10 ‘‘WARNING: Tobacco smoke causes fatal lung dis11 ease in non-smokers’’

12 ‘‘WARNING: Quitting smoking now greatly reduces

13 serious risks to your health’’

14 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

15 ‘‘(A) IN GENERAL.—Each label statement

16 required by paragraph (1) shall be located in

17 the upper portion of the front and rear panels

18 of the package, directly on the package under19 neath the cellophane or other clear wrapping.

20 Except as provided in subparagraph (B), each

21 label statement shall comprise at least the top

22 25 percent of the front and rear panels of the

23 package. The word ‘‘WARNING’’ shall appear

24 in capital letters and all text shall be in con25 spicuous and legible 17-point type, unless the
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1 text of the label statement would occupy more

2 than 70 percent of such area, in which case the

3 text may be in a smaller conspicuous and leg4 ible type size, provided that at least 60 percent

5 of such area is occupied by required text. The

6 text shall be black on a white background, or

7 white on a black background, in a manner that

8 contrasts, by typography, layout, or color, with

9 all other printed material on the package, in an

10 alternating fashion under the plan submitted

11 under subsection (b)(4).

12 ‘‘(B) FLIP-TOP BOXES.—For any cigarette

13 brand package manufactured or distributed be14 fore January 1, 2000, which employs a flip-top

15 style (if such packaging was used for that

16 brand in commerce prior to June 21, 1997), the

17 label statement required by paragraph (1) shall

18 be located on the flip-top area of the package,

19 even if such area is less than 25 percent of the

20 area of the front panel. Except as provided in

21 this paragraph, the provisions of this subsection

22 shall apply to such packages.

23 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU24 TION.—The provisions of this subsection do not

25 apply to a tobacco product manufacturer or dis-
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1 tributor of cigarettes which does not manufacture,

2 package, or import cigarettes for sale or distribution

3 within the United States.

4 ‘‘(b) ADVERTISING REQUIREMENTS.—

5 ‘‘(1) IN GENERAL.—It shall be unlawful for any

6 tobacco product manufacturer, importer, distributor,

7 or retailer of cigarettes to advertise or cause to be

8 advertised within the United States any cigarette

9 unless its advertising bears, in accordance with the

10 requirements of this section, one of the labels speci11 fied in subsection (a) of this section.

12 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement

13 required by subsection (a) of this section in cigarette

14 advertising shall comply with the standards set forth

15 in this paragraph. For press and poster advertise16 ments, each such statement and (where applicable)

17 any required statement relating to tar, nicotine, or

18 other constituent yield shall comprise at least 20

19 percent of the area of the advertisement and shall

20 appear in a conspicuous and prominent format and

21 location at the top of each advertisement within the

22 trim area. The Secretary may revise the required

23 type sizes in such area in such manner as the Sec24 retary determines appropriate. The word ‘‘WARN25 ING’’ shall appear in capital letters, and each label
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1 statement shall appear in conspicuous and legible

2 type. The text of the label statement shall be black

3 if the background is white and white if the back4 ground is black, under the plan submitted under

5 paragraph (4) of this subsection. The label state6 ments shall be enclosed by a rectangular border that

7 is the same color as the letters of the statements

8 and that is the width of the first downstroke of the

9 capital ‘‘W’’ of the word ‘‘WARNING’’ in the label

10 statements. The text of such label statements shall

11 be in a typeface pro rata to the following require12 ments: 45-point type for a whole-page broadsheet

13 newspaper advertisement; 39-point type for a half14 page broadsheet newspaper advertisement; 39-point

15 type for a whole-page tabloid newspaper advertise16 ment; 27-point type for a half-page tabloid news17 paper advertisement; 31.5-point type for a double

18 page spread magazine or whole-page magazine ad19 vertisement; 22.5-point type for a 28 centimeter by

20 3 column advertisement; and 15-point type for a 20

21 centimeter by 2 column advertisement. The label

22 statements shall be in English, except that in the

23 case of—

24 ‘‘(A) an advertisement that appears in a

25 newspaper, magazine, periodical, or other publi-
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1 cation that is not in English, the statements

2 shall appear in the predominant language of the

3 publication; and

4 ‘‘(B) in the case of any other advertise5 ment that is not in English, the statements

6 shall appear in the same language as that prin7 cipally used in the advertisement.

8 ‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec9 retary may, through a rulemaking under section 553

10 of title 5, United States Code, adjust the format and

11 type sizes for the label statements required by this

12 section or the text, format, and type sizes of any re13 quired tar, nicotine yield, or other constituent disclo14 sures, or to establish the text, format, and type sizes

15 for any other disclosures required under the Federal

16 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et

17 seq.). The text of any such label statements or dis18 closures shall be required to appear only within the

19 20 percent area of cigarette advertisements provided

20 by paragraph (2) of this subsection. The Secretary

21 shall promulgate regulations which provide for ad22 justments in the format and type sizes of any text

23 required to appear in such area to ensure that the

24 total text required to appear by law will fit within

25 such area.
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1 ‘‘(4) MARKETING REQUIREMENTS.—

2 ‘‘(A) The label statements specified in sub3 section (a)(1) shall be randomly displayed in

4 each 12-month period, in as equal a number of

5 times as is possible on each brand of the prod6 uct and be randomly distributed in all areas of

7 the United States in which the product is mar8 keted in accordance with a plan submitted by

9 the tobacco product manufacturer, importer,

10 distributor, or retailer and approved by the Sec11 retary.

12 ‘‘(B) The label statements specified in sub13 section (a)(1) shall be rotated quarterly in al14 ternating sequence in advertisements for each

15 brand of cigarettes in accordance with a plan

16 submitted by the tobacco product manufacturer,

17 importer, distributor, or retailer to, and ap18 proved by, the Secretary.

19 ‘‘(C) The Secretary shall review each plan

20 submitted under subparagraph (B) and approve

21 it if the plan—

22 ‘‘(i) will provide for the equal distribu23 tion and display on packaging and the ro24 tation required in advertising under this

25 subsection; and
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1 ‘‘(ii) assures that all of the labels re2 quired under this section will be displayed

3 by the tobacco product manufacturer, im4 porter, distributor, or retailer at the same

5 time.’’.

6 SEC. 8. AUTHORITY TO REVISE CIGARETTE WARNING

7 LABEL STATEMENTS.

8 Section 4 of the Federal Cigarette Labeling and Ad9 vertising Act (15 U.S.C. 1333), as amended by section 4,

10 is further amended by adding at the end the following:

11 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec12 retary may, by a rulemaking conducted under section 553

13 of title 5, United States Code, adjust the format, type size,

14 and text of any of the warning label statements required

15 by subsection (a) of this section subject to the limitation

16 on proportional size of the warning contained in sub17 sections (a)(2) and (b)(2), or establish the format, type

18 size, and text of any other disclosures required under the

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301

20 et seq.), if the Secretary finds that such a change would

21 promote greater public understanding of the risks associ22 ated with the use of smokeless tobacco products.’’.
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1 SEC. 9. SMOKELESS TOBACCO LABELS AND ADVERTISING

2 WARNINGS.

3 Section 3 of the Comprehensive Smokeless Tobacco

4 Health Education Act of 1986 (15 U.S.C. 4402) is amend5 ed to read as follows:

6 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING.

7 ‘‘(a) GENERAL RULE.—

8 ‘‘(1) It shall be unlawful for any person to man9 ufacture, package, or import for sale or distribution

10 within the United States any smokeless tobacco

11 product unless the product package bears, in accord12 ance with the requirements of this Act, one of the

13 following labels:

14 ‘‘WARNING: This product can cause mouth cancer’’

15 ‘‘WARNING: This product can cause gum disease

16 and tooth loss’’

17 ‘‘WARNING: This product is not a safe alternative

18 to cigarettes’’

19 ‘‘WARNING: Smokeless tobacco is addictive’’

20 ‘‘(2) Each label statement required by para21 graph (1) shall be—

22 ‘‘(A) located on the 2 principal display

23 panels of the package, and each label statement

24 shall comprise at least 25 percent of each such

25 display panel; and
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1 ‘‘(B) in 17-point conspicuous and legible

2 type and in black text on a white background,

3 or white text on a black background, in a man4 ner that contrasts by typography, layout, or

5 color, with all other printed material on the

6 package, in an alternating fashion under the

7 plan submitted under subsection (b)(3), except

8 that if the text of a label statement would oc9 cupy more than 70 percent of the area specified

10 by subparagraph (A), such text may appear in

11 a smaller type size, so long as at least 60 per12 cent of such warning area is occupied by the

13 label statement.

14 ‘‘(3) The label statements required by para15 graph (1) shall be introduced by each tobacco prod16 uct manufacturer, packager, importer, distributor, or

17 retailer of smokeless tobacco products concurrently

18 into the distribution chain of such products.

19 ‘‘(4) The provisions of this subsection do not

20 apply to a tobacco product manufacturer or dis21 tributor of any smokeless tobacco product that does

22 not manufacture, package, or import smokeless to23 bacco products for sale or distribution within the

24 United States.

25 ‘‘(b) REQUIRED LABELS.—
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1 ‘‘(1) It shall be unlawful for any tobacco prod2 uct manufacturer, packager, importer, distributor, or

3 retailer of smokeless tobacco products to advertise or

4 cause to be advertised within the United States any

5 smokeless tobacco product unless its advertising

6 bears, in accordance with the requirements of this

7 section, one of the labels specified in subsection (a).

8 ‘‘(2) Each label statement required by sub9 section (a) in smokeless tobacco advertising shall

10 comply with the standards set forth in this para11 graph. For press and poster advertisements, each

12 such statement and (where applicable) any required

13 statement relating to tar, nicotine, or other con14 stituent yield shall—

15 ‘‘(A) comprise at least 20 percent of the

16 area of the advertisement, and the warning area

17 shall be delineated by a dividing line of con18 trasting color from the advertisement; and

19 ‘‘(B) the word ‘‘WARNING’’ shall appear

20 in capital letters and each label statement shall

21 appear in conspicuous and legible type. The text

22 of the label statement shall be black on a white

23 background, or white on a black background, in

24 an alternating fashion under the plan submitted

25 under paragraph (3).
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1 ‘‘(3)(A) The label statements specified in sub2 section (a)(1) shall be randomly displayed in each

3 12-month period, in as equal a number of times as

4 is possible on each brand of the product and be ran5 domly distributed in all areas of the United States

6 in which the product is marketed in accordance with

7 a plan submitted by the tobacco product manufac8 turer, importer, distributor, or retailer and approved

9 by the Secretary.

10 ‘‘(B) The label statements specified in sub11 section (a)(1) shall be rotated quarterly in alter12 nating sequence in advertisements for each brand of

13 smokeless tobacco product in accordance with a plan

14 submitted by the tobacco product manufacturer, im15 porter, distributor, or retailer to, and approved by,

16 the Secretary.

17 ‘‘(C) The Secretary shall review each plan sub18 mitted under subparagraph (B) and approve it if the

19 plan—

20 ‘‘(i) will provide for the equal distribution

21 and display on packaging and the rotation re22 quired in advertising under this subsection; and

23 ‘‘(ii) assures that all of the labels required

24 under this section will be displayed by the to-
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1 bacco product manufacturer, importer, dis2 tributor, or retailer at the same time.

3 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is

4 unlawful to advertise smokeless tobacco on any medium

5 of electronic communications subject to the jurisdiction of

6 the Federal Communications Commission.’’.

7 SEC. 10. AUTHORITY TO REVISE SMOKELESS TOBACCO

8 PRODUCT WARNING LABEL STATEMENTS.

9 Section 3 of the Comprehensive Smokeless Tobacco

10 Health Education Act of 1986 (15 U.S.C. 4402), as

11 amended by section 6, is further amended by adding at

12 the end the following:

13 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

14 STATEMENTS.—The Secretary may, by a rulemaking con15 ducted under section 553 of title 5, United States Code,

16 adjust the format, type size, and text of any of the warn17 ing label statements required by subsection (a) of this sec18 tion, subject to the limitations on proportional size of the

19 warning contained in paragraphs (2) and (3) of subsection

20 (a), or establish the format, type size, and text of any

21 other disclosures required under the Federal Food, Drug,

22 and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary

23 finds that such a change would promote greater public un24 derstanding of the risks associated with the use of smoke25 less tobacco products.’’.
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1 SEC. 11. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT

2 DISCLOSURE TO THE PUBLIC.

3 Section 4(a) of the Federal Cigarette Labeling and

4 Advertising Act (15 U.S.C. 1333(a)), as amended by sec5 tion 4, is further amended by adding at the end the fol6 lowing:

7 ‘‘(4)(A) The Secretary shall, by a rulemaking

8 conducted under section 553 of title 5, United

9 States Code, determine (in the Secretary’s sole dis10 cretion) whether cigarette and other tobacco product

11 manufacturers shall be required to include in the

12 area of each cigarette advertisement specified by

13 subsection (b) of this section, or on the package

14 label, or both, the tar and nicotine yields of the ad15 vertised or packaged brand. Any such disclosure

16 shall be in accordance with the methodology estab17 lished under such regulations, shall conform to the

18 type size requirements of subsection (b) of this sec19 tion, and shall appear within the area specified in

20 subsection (b) of this section.

21 ‘‘(B) Any differences between the requirements

22 established by the Secretary under subparagraph (A)

23 and tar and nicotine yield reporting requirements es24 tablished by the Federal Trade Commission shall be

25 resolved by a memorandum of understanding be-
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1 tween the Secretary and the Federal Trade Commis2 sion.

3 ‘‘(C) In addition to the disclosures required by

4 subparagraph (A) of this paragraph, the Secretary

5 may, under a rulemaking conducted under section

6 553 of title 5, United States Code, prescribe disclo7 sure requirements regarding the level of any ciga8 rette or other tobacco product smoke constituent.

9 Any such disclosure may be required if the Secretary

10 determines that disclosure would be of benefit to the

11 public health, or otherwise would increase consumer

12 awareness of the health consequences of the use of

13 tobacco products, except that no such prescribed dis14 closure shall be required on the face of any cigarette

15 package or advertisement. Nothing in this section

16 shall prohibit the Secretary from requiring such pre17 scribed disclosure through a cigarette or other to18 bacco product package or advertisement insert, or by

19 any other means under the Federal Food, Drug, and

20 Cosmetic Act (21 U.S.C. 301 et seq.).’’.

21 SEC. 12. REGULATION REQUIREMENT.

22 (a) TESTING, REPORTING, AND DISCLOSURE.—Not

23 later than 24 months after the date of enactment of this

24 Act, the Secretary, through the Commissioner of the Food

25 and Drug Administration, shall promulgate regulations
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1 under the Federal Food, Drug, and Cosmetic Act (21

2 U.S.C. 301 et seq.) that meet the requirements of sub3 section (b) of this section.

4 (b) CONTENTS OF RULES.—The rules promulgated

5 under subsection (a) shall require the testing, reporting,

6 and disclosure of tobacco product smoke constituents and

7 ingredients that the Secretary determines should be dis8 closed to the public in order to protect the public health.

9 Such constituents shall include tar, nicotine, carbon mon10 oxide, and such other smoke constituents or ingredients

11 as the Secretary may determine to be appropriate. The

12 rule may require that tobacco product manufacturers,

13 packagers, or importers make such disclosures relating to

14 tar and nicotine through labels or advertising, and make

15 such disclosures regarding other smoke constituents or in16 gredients as the Secretary determines are necessary to

17 protect the public health.

18 (c) AUTHORITY.—The Food and Drug Administra19 tion shall have authority to conduct or to require the test20 ing, reporting, or disclosure of tobacco product smoke con21 stituents.

22 SEC. 13. FTC JURISDICTION NOT AFFECTED.

23 (a) IN GENERAL.—Except where expressly provided

24 in this Act, nothing in this Act shall be construed as lim25 iting or diminishing the authority of the Federal Trade
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1 Commission to enforce the laws under its jurisdiction with

2 respect to the advertising, sale, or distribution of tobacco

3 products.

4 (b) ENFORCEMENT BY FTC.—Any advertising that

5 violates this Act is an unfair or deceptive act or practice

6 under section 5(a) of the Federal Trade Commission Act

7 (15 U.S.C. 45(a)) and shall be considered a violation of

8 a rule promulgated under section 18 of that Act (15

9 U.S.C. 57a).

Æ