II

106TH CONGRESS

2D SESSION S. 2125

To provide for the disclosure of certain information relating to tobacco products and to prescribe labels for packages and advertising of tobacco

products.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 29, 2000

Mr. LAUTENBERG (for himself, Mr. LUGAR, Mr. DURBIN, Mr. L. CHAFEE)

introduced the following bill; which was read twice and referred to the

Committee on Commerce, Science, and Transportation

A BILL

To provide for the disclosure of certain information relating

to tobacco products and to prescribe labels for packages

and advertising of tobacco products.

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 ‘‘Smoker’s Right to

5 Know and Truth in Tobacco Labeling Act’’.

6 SEC. 2. DEFINITIONS.

7 In this Act:

8 (1) ADVERTISEMENT.—The term ‘‘advertise9 ment’’ means all newspapers and magazine adver-
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1 tisements and advertising inserts, billboards, posters,

2 signs, decals, banners, matchbook advertising, point3 of-purchase display material and all other written or

4 other material used for promoting the sale or con5 sumption of tobacco products to consumers, and ad6 vertising at an Internet site.

7 (2) BRAND.—The term ‘‘brand’’ means a vari8 ety of tobacco products distinguished by the tobacco

9 used, tar and nicotine content, flavoring used, size

10 of the tobacco product, filtration, or packaging.

11 (3) BRAND STYLE.—The term ‘‘brand style’’

12 means a variety of cigarettes distinguished by the to13 bacco used, tar and nicotine content, flavoring used,

14 size of the cigarette, filtration on the cigarette, or

15 packaging.

16 (4) CARCINOGEN.—The term ‘‘carcinogen’’

17 means any agent that is determined to be

18 tumorigenic according to the National Toxicology

19 Program or the International Agency for Research

20 on Cancer, or that is otherwise known by the manu21 facturer to be tumorigenic.

22 (5) CIGAR.—The term ‘‘cigar’’ means any roll

23 of tobacco wrapped in leaf tobacco or in any sub24 stance containing tobacco, that weighs 3 pounds or
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1 more per thousand, and is not a cigarette or little

2 cigar.

3 (6) CIGARETTE.—The term ‘‘cigarette’’

4 means—

5 (A) any roll of tobacco wrapped in paper

6 or tobacco leaf or in any substance not con7 taining tobacco which is to be burned,

8 (B) any roll of tobacco wrapped in any

9 substance containing tobacco which, because of

10 its appearance, the type of tobacco used in the

11 filler, or its packaging or labeling is likely to be

12 offered to, or purchased by consumers as a cig13 arette described in subparagraph (A),

14 (C) little cigars which are any roll of to15 bacco wrapped in leaf tobacco or any substance

16 containing tobacco (other than any roll of to17 bacco which is a cigarette within the meaning

18 of subparagraph (A)) and as to which 1,000

19 units weigh not more than 3 pounds, and

20 (D) loose rolling tobacco that, because of

21 its appearance, type, packaging, or labeling, is

22 likely to be offered to, or purchased by, con23 sumers as tobacco for making cigarettes.

24 (7) COMMERCE.—The term ‘‘commerce’’

25 means—
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1 (A) commerce between any State, the Dis2 trict of Columbia, the Commonwealth of Puerto

3 Rico, Guam, the Virgin Islands, American

4 Samoa, Wake Island, Midway Islands, Kingman

5 Reef, or Johnston Island and any place outside

6 thereof;

7 (B) commerce between points in any State,

8 the District of Columbia, the Commonwealth of

9 Puerto Rico, Guam, the Virgin Islands, Amer10 ican Samoa, Wake Island, Midway Islands,

11 Kingman Reef, or Johnston Island, but through

12 any place outside thereof; or

13 (C) commerce wholly within the District of

14 Columbia, Guam, the Virgin Islands, American

15 Samoa, Wake Island, Midway Islands, Kingman

16 Reef, or Johnston Island.

17 (8) CONSTITUENT.—The term ‘‘constituent’’

18 means any element of tobacco or cigarette main19 stream or sidestream smoke, including tar, the com20 ponents of the tar, nicotine, and carbon monoxide or

21 any other component designated by the Secretary.

22 (9) DISTRIBUTOR.—The term ‘‘distributor’’

23 does not include a retailer and the term ‘‘distribute’’

24 does not include retail distribution.
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1 (10) INGREDIENT.—The term ‘‘ingredient’’

2 means any substance the use of which results, or

3 may reasonably be expected to result, directly or in4 directly, in its becoming a component of any tobacco

5 product, including any component of the paper or

6 filter of such product.

7 (11) PACKAGE.—The term ‘‘package’’ means a

8 pack, box, carton, or other container of any kind in

9 which cigarettes or other tobacco products are of10 fered for sale, sold, or otherwise distributed to cus11 tomers.

12 (12) PERSON.—The term ‘‘person’’ means an

13 individual, partnership, corporation, or any other

14 business or legal entity.

15 (13) PIPE TOBACCO.—The term ‘‘pipe tobacco’’

16 means any loose tobacco that, because of its appear17 ance, type, packaging, or labeling, is likely to be of18 fered to, or purchased by, consumers as a tobacco

19 product to be smoked in a pipe.

20 (14) SALE OR DISTRIBUTION.—The term ‘‘sale

21 or distribution’’ includes sampling or any other dis22 tribution not for sale.

23 (15) SECRETARY.—The term ‘‘Secretary’’

24 means the Secretary of Health and Human Services.
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1 (16) SMOKELESS TOBACCO.—The term ‘‘smoke2 less tobacco’’ means any product that includes cut,

3 ground, powdered, or leaf tobacco that is intended to

4 be placed in the oral or nasal cavity.

5 (17) STATE.—The term ‘‘State’’ includes, in

6 addition to the 50 States, the District of Columbia,

7 Guam, the Commonwealth of Puerto Rico, the

8 Northern Mariana Islands, the Virgin Islands,

9 American Samoa, and the Trust Territory of the Pa10 cific Islands.

11 (18) TAR.—The term ‘‘tar’’ means the particu12 late matter from tobacco smoke minus water and

13 nicotine.

14 (19) TOBACCO PRODUCT.—The term ‘‘tobacco

15 product’’ means any product made of or derived

16 from tobacco leaf for human consumption, including

17 cigarettes, cigars, little cigars, loose tobacco, smoke18 less tobacco, and pipe tobacco.

19 (20) TRADEMARK.—The term ‘‘trademark’’

20 means any word, name, symbol, logo, or device or

21 any combination thereof used by a person to identify

22 or distinguish such person’s goods from those manu23 factured or sold by another person and to indicate

24 the source of the goods.
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1 (21) UNITED STATES.—The term ‘‘United

2 States’’ includes the States and installations of the

3 Armed Forces of the United States located outside

4 a State.

5 SEC. 3. CIGARETTE PRODUCT PACKAGE LABELING; ADVER6 TISING WARNINGS.

7 (a) WARNING LABELS.—

8 (1) IN GENERAL.—It shall be unlawful for any

9 person to manufacture, package, or import for sale

10 or distribution within the United States any ciga11 rettes the package of which fails to bear, in accord12 ance with the requirements of this section, one of

13 the following label statements:

14 WARNING: Cigarettes are addictive

15 WARNING: Tobacco smoke can harm your

16 children

17 WARNING: Cigarettes cause fatal lung disease

18 WARNING: Cigarettes cause cancer

19 WARNING: Cigarettes cause strokes and heart

20 disease

21 WARNING: Smoking during pregnancy can

22 harm your baby

23 WARNING: Smoking can kill you

24 WARNING: Tobacco smoke causes fatal lung

25 disease in non-smokers
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1 WARNING: Quitting smoking now greatly re2 duces serious risks to your health

3 WARNING: Smoking causes sexual dysfunc4 tion.

5 (2) LIST OF CARCINOGENS.—

6 (A) IN GENERAL.—It shall be unlawful for

7 any person to manufacture, package, or import

8 for sale or distribution in the United States any

9 cigarettes the package of which fails to bear, in

10 accordance with the requirements of this sec11 tion, a statement that lists in the manner and

12 order as required by subparagraph (B) certain

13 carcinogens present in that cigarette brand’s in14 gredients or constituents.

15 (B) STATEMENT REQUIRED.—The state16 ment required under subparagraph (A) shall—

17 (i) be listed as follows:

18 ‘‘CANCER-CAUSING AGENTS: The

19 following cancer-causing agents are inhaled

20 in this product’s smoke: [list of carcino21 gens]’’;

22 (ii) in the bracketed area in the state23 ment described in clause (i), list carcino24 gens in the following categories that are

25 present in that cigarette brand’s ingredi-
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1 ents or constituents in the following de2 scending order—

3 (I) inorganic compounds;

4 (II) miscellaneous organic com5 pounds;

6 (III) aldehydes;

7 (IV) carcinogenic tobacco-specific

8 nitrosamines (TSNAs).

9 (V) volatile nitrosamines; and

10 (VI) if any other carcinogens are

11 present, state the following: ‘‘and

12 other carcinogens’’; and

13 (iii) display, in bold print, the percent14 age of any carcinogen listed in clause (ii)

15 relative to the average of such concentra16 tion of such carcinogen in the sales weight17 ed average of all cigarettes marketed in the

18 United States.

19 (3) PLACEMENT; TYPOGRAPHY.—

20 (A) WARNING LABELS.—Each label state21 ment required by paragraph (1) shall be located

22 in the upper portion of the front and rear pan23 els of the package, directly on the package un24 derneath the cellophane or other clear wrap25 ping. Each label statement shall comprise at
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1 least the top 33 percent of the front and rear

2 panels of the package. The word ‘‘WARNING’’

3 shall appear in capital letters and all text shall

4 be in conspicuous and legible 17-point bold,

5 uncondensed, sans serif type. Notwithstanding

6 the preceding sentence, the point size may be

7 reduced when the longest line of text exceeds 16

8 typographic characters (letters and space), ex9 cept that such reduced point size may never be

10 smaller than 15-point and at least 60 percent

11 of the area involved shall be occupied by the re12 quired text. The text shall be black on a white

13 background, or white on a black background, in

14 a manner that contrasts, by typography, layout,

15 or color, with all other printed material on the

16 package, in an alternating fashion under the

17 plan submitted under subsection (c)(4).

18 (B) LIST OF CARCINOGENS.—Each state19 ment required by paragraph (2) shall be located

20 in the same place that label statements were

21 placed on cigarette packages as of October 12,

22 1984. The text of the statement shall be in con23 spicuous and legible 9-point uncondensed, sans

24 serif type and shall appear in a conspicuous and

25 prominent format on 1 side of the package. The
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1 Secretary may revise type sizes for the text in

2 such an area and in such a manner as the Sec3 retary determines to be appropriate. The term

4 ‘‘CANCER-CAUSING AGENTS’’ shall appear

5 in bold capital letters, and the text shall be

6 black on a white background, or white on a

7 black background, in a manner that contrasts,

8 by typography, layout, or color, with all other

9 printed material on the package, except the

10 label statement required under paragraph (1).

11 (4) DOES NOT APPLY TO FOREIGN DISTRIBU12 TION.—The provisions of this subsection do not

13 apply to a manufacturer or distributor of cigarettes

14 which does not manufacture, package, or import

15 cigarettes for sale or distribution within the United

16 States.

17 (b) PACKAGE INSERT.—

18 (1) IN GENERAL.—It shall be unlawful for any

19 person to manufacture, import, package, or dis20 tribute for sale within the United States any ciga21 rettes unless the cigarette package includes a pack22 age insert, prepared in accordance with guidelines

23 established by the Secretary by regulation, on car24 cinogens, toxins, and other substances posing a risk

25 to human health that are contained in the ingredi-
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1 ents and constituents of the cigarettes in such pack2 age. The Secretary shall include in such guidelines

3 information on the health impact of smoking and

4 smoking cessation as determined to be necessary by

5 the Secretary to advance public health.

6 (2) REGULATIONS.—The Secretary shall issue

7 regulations requiring the package insert required by

8 paragraph (1) to provide the information required by

9 such paragraph (including carcinogens and other

10 dangerous substances) in a prominent, clear fashion

11 and a detailed list of the ingredients and constitu12 ents.

13 (c) ADVERTISING REQUIREMENTS.—

14 (1) IN GENERAL.—It shall be unlawful for any

15 manufacturer, importer, distributor, or retailer of

16 cigarettes to advertise or cause to be advertised

17 within the United States any cigarette, or any simi18 lar tobacco product, unless its advertising bears, in

19 accordance with the requirements of this section—

20 (A) one of the label statements specified in

21 paragraph (1) of subsection (a); and

22 (B) a list of carcinogens specified in para23 graph (2) of subsection (a).

24 (2) TYPOGRAPHY.—

25 (A) WARNINGS.—
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1 (i) IN GENERAL.—Each cigarette ad2 vertisement shall include a label statement

3 required by subsection (a)(1) as set forth

4 in this subparagraph.

5 (ii) ADVERTISEMENTS.—For press

6 (including magazine and newspaper), post7 er and billboard advertisements, each such

8 label statement shall comprise at least 30

9 percent of the area of the advertisement

10 and shall appear in a conspicuous and

11 prominent format and location at the top

12 of each advertisement within the printing

13 safety area. The Secretary may revise the

14 required type sizes in such area in such

15 manner as the Secretary determines appro16 priate to advance public health.

17 (iii) TEXT.—The word ‘‘WARNING’’

18 shall appear in capital letters, and each

19 label statement shall appear in con20 spicuous, uncondensed, bold, sans serif

21 type. The text of the label statement shall

22 be black if the background is white and

23 white if the background is black, under the

24 plan submitted under paragraph (4). The

25 label statements shall be enclosed by a rec-
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1 tangular border that is the same color as

2 the letters of the statements and that is

3 twice the width of the vertical stroke of the

4 letter ‘‘I’’ in the word ‘‘WARNING’’ in the

5 label statements.

6 (iv) POINT TYPE.—The text of such

7 label statements shall be in a bold typeface

8 pro rata to the following requirements:

9 (I) 45-point type for a whole10 page broadsheet newspaper advertise11 ment.

12 (II) 39-point type for a half-page

13 broadsheet newspaper advertisement.

14 (III) 39-point type for a whole15 page tabloid newspaper advertisement.

16 (IV) 27-point type for a half-page

17 tabloid newspaper advertisement.

18 (V) 31.5-point type for a double

19 page spread magazine or whole-page

20 magazine advertisement.

21 (VI) 22.5-point type for a 28

22 centimeter by 3 column advertise23 ment.

24 (VII) 15-point type for a 20 cen25 timeter by 2 column advertisement.
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1 (v) BILLBOARDS.—For billboard ad2 vertisements, the typeface shall be adjusted

3 so that the text occupies 60–70 percent of

4 the label area. The warning label on bill5 boards that use artificial lighting shall not

6 be less visible than other printed matter on

7 the billboard when the lighting is in use.

8 (vi) ALL LABEL STATEMENTS.—The

9 label statements shall be in English, except

10 that in the case of—

11 (I) an advertisement that ap12 pears in a newspaper, magazine, peri13 odical, or other publication that is not

14 in English, the statements shall ap15 pear in the predominant language of

16 the publication; and

17 (II) in the case of any other ad18 vertisement that is not in English, the

19 label statements shall appear in the

20 same language as that principally

21 used in the advertisement.

22 (B) LIST OF CARCINOGENS.—Each state23 ment required by subsection (a)(2) in cigarette

24 advertising shall comply with the standards set

25 forth in this subparagraph. For press, poster
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1 and billboard advertisements, each such state2 ment shall appear in a conspicuous and promi3 nent format and be located at the bottom of

4 each advertisement within the printing safety

5 area. Each such statement shall comprise not

6 less than 15 percent of the area of the adver7 tisement, with the text of the statement com8 prising not less than 60 percent and not more

9 than 70 percent of such an area. The Secretary

10 may designate required type sizes in such an

11 area in such a manner as the Secretary deter12 mines appropriate to advance public health. The

13 text of such a statement shall be black if the

14 background is white, and white if the back15 ground is black, and shall be in type that is

16 otherwise in contrast in typography, layout, or

17 color with all other printed material in the ad18 vertisement.

19 (3) ADJUSTMENT BY SECRETARY.—The Sec20 retary may, through a rulemaking under section 553

21 of title 5, United States Code, adjust the format and

22 type sizes and content for the label statements re23 quired by this section or the text, format, and type

24 sizes of any required tar, nicotine yield, or other

25 constituent disclosures, or to establish the text, for-
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1 mat, and type sizes for any other disclosures re2 quired under the Federal Food, Drug, and Cosmetic

3 Act (21 U.S.C. 301 et seq.). The text of any such

4 label statements or disclosures shall be required to

5 appear only within the 30 percent area of cigarette

6 advertisements provided by paragraph (2). The Sec7 retary shall promulgate regulations which provide

8 for adjustments in the format and type sizes of any

9 text required to appear in such area to ensure that

10 the total text required to appear by law will fit with11 in such area.

12 (4) MARKETING REQUIREMENTS.—

13 (A) IN GENERAL.—The label statements

14 specified in subsection (a)(1) shall be randomly

15 displayed in each 12-month period, in as equal

16 a number of times as is possible on each brand

17 and brand style of the product and be randomly

18 distributed in all areas of the United States in

19 which the product is marketed in accordance

20 with a plan submitted by the cigarette manufac21 turer, importer, distributor, or retailer, and ap22 proved by the Secretary.

23 (B) ROTATION.—The label statements

24 specified in subsection (a)(1) shall be rotated

25 quarterly in alternating sequence in advertise-
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1 ments for each brand and brand style of ciga2 rettes in accordance with a plan submitted by

3 the cigarette manufacturer, importer, dis4 tributor, or retailer to, and approved by, the

5 Secretary.

6 (C) REVIEW OF PLAN.—The Secretary

7 shall review each plan submitted under sub8 paragraph (B) and approve it if the plan—

9 (i) will provide for the equal distribu10 tion and display on packaging and the ro11 tation required in advertising under this

12 subsection; and

13 (ii) assures that all of the label state14 ments required under this section will be

15 displayed by the cigarette manufacturer,

16 importer, distributor, or retailer at the

17 same time.

18 (d) TELEVISION AND RADIO ADVERTISING.—It is un19 lawful to advertise cigarettes on any medium of electronic

20 communications subject to the jurisdiction of the Federal

21 Communications Commission.

22 SEC. 4. LABELS AND ADVERTISING WARNINGS FOR SMOKE23 LESS TOBACCO, CIGARS, AND PIPE TOBACCO.

24 (a) WARNING LABELS.—
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1 (1) IN GENERAL.—It shall be unlawful for any

2 person to manufacture, package, or import for sale

3 or distribution within the United States any smoke4 less tobacco product, cigar product, or pipe tobacco

5 product, or any similar tobacco product, unless the

6 product package bears, in accordance with the re7 quirements of this Act, one of the following label

8 statements:

9 (A) Any smokeless tobacco product shall

10 bear one of the following label statements:

11 WARNING: Smokeless tobacco causes mouth

12 cancer

13 WARNING: Smokeless tobacco causes gum dis14 ease and tooth loss

15 WARNING: Smokeless tobacco is not a safe al16 ternative to cigarettes

17 WARNING: Smokeless tobacco is addictive

18 (B) Any cigar product shall bear one of

19 the following label statements:

20 WARNING: Cigar smoke causes mouth cancer

21 WARNING: Cigar smoke causes throat cancer

22 WARNING: Cigar smoke causes lung cancer

23 WARNING: Cigars are not a safe alternative to

24 cigarettes
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1 WARNING: Cigar smoke can harm your chil2 dren

3 (C) Any pipe tobacco product shall bear

4 one of the following label statements:

5 WARNING: Pipe smoking causes mouth cancer

6 WARNING: Pipe smoking causes throat cancer

7 WARNING: Pipe smoking is not a safe alter8 native to cigarettes

9 WARNING: Pipe smoking can harm your chil10 dren

11 (2) REQUIREMENTS.—

12 (A) LOCATION OF LABEL STATEMENT.—

13 Each label statement required by paragraph (1)

14 shall—

15 (i) for any smokeless tobacco or pipe

16 tobacco product, be located on the 2 prin17 cipal display panels of the product pack18 age, and comprise at least 25 percent of

19 each such display panel; and

20 (ii) for any cigar product, be located

21 on a band around each cigar that is pack22 aged for individual sale, and for each pack23 age of cigars, be located in the upper por24 tion of the front and rear panels of the

25 package and comprise at least the top 33
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1 percent of the front and rear panels of the

2 package.

3 (B) SIZE AND TEXT OF LABEL STATE4 MENT.—Each label statement required by para5 graph (1) shall be in 17-point bold,

6 uncondensed, sans serif type and in black text

7 on a white background, or white text on a black

8 background, in a manner that contrasts by ty9 pography, layout, or color, with all other print10 ed material on the package or band, in an alter11 nating fashion under the plan submitted under

12 subsection (b)(3), except that if the text of a

13 label statement would occupy more than 70 per14 cent of the area specified by subparagraph (A),

15 such text may appear in a smaller type size, so

16 long as at least 60 percent of such warning

17 area is occupied by the label statement.

18 (3) INTRODUCTION.—The label statements re19 quired by paragraph (1) shall be introduced by each

20 manufacturer, packager, importer, distributor, or re21 tailer of smokeless tobacco products, cigar products,

22 and pipe tobacco products concurrently into the dis23 tribution chain of such products.

24 (4) DOES NOT APPLY TO FOREIGN DISTRIBU25 TION.—The provisions of this subsection do not
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1 apply to a manufacturer or distributor of any

2 smokeless tobacco product, cigar product, or pipe to3 bacco product that does not manufacture, package,

4 or import such products for sale or distribution

5 within the United States.

6 (b) ADVERTISEMENTS.—

7 (1) IN GENERAL.—It shall be unlawful for any

8 manufacturer, packager, importer, distributor, or re9 tailer of smokeless tobacco products, cigar products,

10 or pipe tobacco products to advertise or cause to be

11 advertised within the United States any such prod12 uct unless its advertising bears, in accordance with

13 the requirements of this section, one of the label

14 statements specified in subsection (a) that is appli15 cable to such product.

16 (2) REQUIREMENTS.—Each label statement re17 quired by paragraph (1) shall comply with the

18 standards set forth in this paragraph. For press and

19 poster advertisements, each such statement and

20 (where applicable) any required statement relating

21 to tar, nicotine, or other constituent yield shall—

22 (A) comprise at least 20 percent of the

23 area of the advertisement, and the warning area

24 shall be delineated by a dividing line of con25 trasting color from the advertisement; and
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1 (B) the word ‘‘WARNING’’ shall appear in

2 capital letters and each label statement shall

3 appear in conspicuous and legible type.

4 The text of the label statement shall be black on a

5 white background, or white on a black background,

6 in an alternating fashion under the plan submitted

7 under paragraph (3).

8 (3) DISPLAY.—

9 (A) RANDOM DISPLAY.—The label state10 ments specified in subsection (a)(1) shall be

11 randomly displayed in each 12-month period, in

12 as equal a number of times as is possible on

13 each brand of the product and be randomly dis14 tributed in all areas of the United States in

15 which the product is marketed in accordance

16 with a plan submitted by the manufacturer, im17 porter, distributor, or retailer of smokeless to18 bacco products, cigar products, or pipe tobacco

19 products and approved by the Secretary.

20 (B) ROTATION.—The label statements

21 specified in subsection (a)(1) shall be rotated

22 quarterly in alternating sequence in advertise23 ments for each brand of smokeless tobacco

24 product, cigar product, and pipe tobacco prod25 uct, in accordance with a plan submitted by the
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1 tobacco product manufacturer, importer, dis2 tributor, or retailer to, and approved by, the

3 Secretary.

4 (C) REVIEW OF PLAN.—The Secretary

5 shall review each plan submitted under sub6 paragraph (B) and approve it if the plan—

7 (i) will provide for the equal distribu8 tion and display on packaging and the ro9 tation required in advertising under this

10 subsection; and

11 (ii) assures that all of the label state12 ments required under this section will be

13 displayed by the manufacturer, importer,

14 distributor, or retailer of smokeless tobacco

15 products, cigar products, or pipe tobacco

16 products, at the same time.

17 (c) PACKAGE INSERT.—

18 (1) IN GENERAL.—It shall be unlawful for any

19 person to manufacture, import, package, or dis20 tribute for sale within the United States any smoke21 less tobacco product, cigar product, or pipe tobacco

22 product unless such product, not including a cigar

23 that is sold individually, includes a package insert,

24 prepared in accordance with guidelines established

25 by the Secretary by regulation, on carcinogens, tox-
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1 ins, and other substances posing a risk to human

2 health that are contained in the ingredients and con3 stituents of such product. The Secretary shall in4 clude in such guidelines information on the health

5 impact of smoking and smoking cessation as the

6 Secretary determines to be necessary to advance

7 public health.

8 (2) REGULATIONS.—The Secretary shall issue

9 regulations requiring the package insert required by

10 paragraph (1) to provide the information required by

11 such paragraph (including carcinogens and other

12 dangerous substances) in a prominent, clear fashion

13 and a detailed list of the ingredients and constitu14 ents.

15 (d) TELEVISION AND RADIO ADVERTISING.—It is un16 lawful to advertise smokeless tobacco product, cigar prod17 uct, or pipe tobacco product on any medium of electronic

18 communications subject to the jurisdiction of the Federal

19 Communications Commission.

20 SEC. 5. AUTHORITY TO REVISE WARNING LABEL STATE21 MENTS.

22 The Secretary may, by a rulemaking conducted under

23 section 553 of title 5, United States Code, adjust the for24 mat, type size, content, and text of any of the warning

25 label statements required by this Act, or establish the for-
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1 mat, type size, and text of any other disclosures required

2 under the Federal Food, Drug, and Cosmetic Act (21

3 U.S.C. 301 et seq.), or alter the list of carcinogens dis4 closed on label statements, if the Secretary finds that such

5 a change would promote greater public understanding of

6 the risks associated with the use of tobacco.

7 SEC. 6. TOBACCO PRODUCT INGREDIENTS AND CONSTITU8 ENTS.

9 (a) GENERAL RULE.—Each person that manufac10 tures, packages, or imports into the United States any to11 bacco product shall annually report, in a form and at a

12 time specified by the Secretary by regulation—

13 (1) the identity of any added ingredient or con14 stituent of the product other than tobacco, water, or

15 reconstituted tobacco sheet made wholly from to16 bacco; and

17 (2) the nicotine, tar, and carbon monoxide yield

18 ratings which shall accurately predict the nicotine,

19 tar, and carbon monoxide intake from such product

20 for average consumers based on standards estab21 lished by the Secretary by regulation;

22 if such information is not information which the Secretary

23 determines to be trade secret or confidential information

24 subject to section 552(b)(4) of title 5, United States Code,

25 and section 1905 of title 18, United States Code. The in-
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1 gredients and constituents identified under paragraph (1)

2 shall be listed in descending order according to weight,

3 measure, or numerical count. If any of such constituents

4 are carcinogens, or otherwise poses a risk to human health

5 as determined by the Secretary, such information shall be

6 included in the report.

7 (b) PUBLIC DISSEMINATION.—The Secretary shall

8 review the information contained in each report submitted

9 under subsection (a) and if the Secretary determines that

10 such information directly affects the public health, the

11 Secretary shall require that such information be included

12 in a label under sections 3 and 4.

13 (c) OTHER SOURCES OF INFORMATION.—The Sec14 retary shall establish a toll-free telephone number and a

15 site on the Internet which shall make available additional

16 information on the ingredients of such tobacco products,

17 except information which the Secretary determines to be

18 trade secret or confidential information subject to section

19 552(b)(4) of title 5, United States Code, and section 1905

20 of title 18, United States Code.

21 SEC. 7. ENFORCEMENT.

22 (a) IN GENERAL.—

23 (1) REGULATIONS.—The Secretary shall issue

24 such regulations as may be appropriate for the im25 plementation of this Act. The Secretary shall issue
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1 proposed regulations for such implementation within

2 180 days of the date of the enactment of this Act.

3 Not later than 180 days after the date of the publi4 cation of such proposed regulations, the Secretary

5 shall issue final regulations for such implementation.

6 If the Secretary does not issue such final regulations

7 before the expiration of such 180 days, the proposed

8 regulations shall become final and the Secretary

9 shall publish a notice in the Federal Register about

10 the new status of the proposed regulations.

11 (2) CONSULTATION.—In carrying out the Sec12 retary’s duties under this Act, the Secretary shall,

13 as appropriate, consult with such experts as may

14 have appropriate training and experience in the mat15 ters subject to such duties.

16 (3) MONITORING OF COMPLIANCE.—The Sec17 retary shall monitor compliance with the require18 ments of this Act.

19 (4) RECOMMENDATION FOR ENFORCEMENT.—

20 The Secretary shall recommend to the Attorney Gen21 eral such enforcement actions as may be appropriate

22 under this Act.

23 (b) INJUNCTION.—

24 (1) IN GENERAL.—The district courts of the

25 United States shall have jurisdiction over civil ac-
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1 tions brought to restrain violations of this Act. Such

2 a civil action may be brought in the United States

3 district court for the judicial district in which any

4 substantial portion of the violation occurred or in

5 which the defendant is found or transacts business.

6 In such a civil action, process may be served on a

7 defendant in any judicial district in which the de8 fendant resides or may be found and subpoenas re9 quiring attendance of witnesses in any such action

10 may be served in any judicial district.

11 (2) ACTIONS BY INTERESTED PARTIES.—Any

12 interested organization may bring a civil action de13 scribed in paragraph (1). If such an organization

14 substantially prevails in such an action, the court

15 may award it reasonable attorney’s fees and ex16 penses. For purposes of this paragraph, the term

17 ‘‘interested organization’’ means any nonprofit orga18 nization one of whose purposes, and a substantial

19 part of its activities, include the promotion of public

20 health through reduction in the use of tobacco prod21 ucts.

22 (c) CIVIL PENALTY.—Any person who manufactures,

23 packages, distributes, or advertises a tobacco product in

24 violation of this Act shall be subject to a civil penalty of

25 not more than $100,000 for each violation per day.
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1 SEC. 8. REPORT TO CONGRESS BY THE SECRETARY.

2 Not later than 36 months after the date of enactment

3 of this Act and biannually thereafter, the Secretary shall

4 transmit to the Congress a report describing actions taken

5 pursuant to this Act, current practices and methods of to6 bacco advertising and promotion, and recommendations if

7 any for legislation.

8 SEC. 9. EFFECTIVE DATES AND CONFORMING AMEND9 MENTS.

10 (a) EFFECTIVE DATE.—This Act shall take effect on

11 the date of the enactment of this Act, except that section

12 3, 4, 5 and 6 shall take effect 1 year after the date of

13 the enactment of this Act.

14 (b) CONFORMING AMENDMENTS.—Effective on the

15 date that is 1 year from the date of the enactment of this

16 Act, the Federal Cigarette Labeling and Advertising Act

17 (15 U.S.C. 1331 et seq.) and the Comprehensive Smoke18 less Tobacco Health Education Act of 1986 (15 U.S.C.

19 4401) are repealed.

Æ