II

106TH CONGRESS

2D SESSION S. 2568

To protect the public health by providing the Food and Drug Administration

with certain authority to regulate tobacco products.

IN THE SENATE OF THE UNITED STATES

MAY 16, 2000

Mr. KENNEDY (for himself, Mr. LAUTENBERG, Mr. DURBIN, Mr. KERRY, and

Mr. WELLSTONE) introduced the following bill; which was read twice and

referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To protect the public health by providing the Food and

Drug Administration with certain authority to regulate

tobacco products.

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; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Youth Smoking Prevention and Public Health Protection

6 Act’’.

7 (b) TABLE OF CONTENTS.—The table of contents of

8 this Act is as follows:

Sec. 1. Short title.

Sec. 2. Findings.
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Sec. 3. Purpose.

Sec. 4. Scope and effect.

TITLE I—AUTHORITY OF THE FOOD AND DRUG

ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.

‘‘CHAPTER IX—TOBACCO PRODUCTS

‘‘Sec. 900. Definitions.

‘‘Sec. 901. FDA authority over tobacco products

‘‘Sec. 902. Adulterated tobacco products.

‘‘Sec. 903. Misbranded tobacco products.

‘‘Sec. 904. Submission of health information to the Secretary.

‘‘Sec. 905. Annual registration.

‘‘Sec. 906. General provisions respecting control of tobacco products.

‘‘Sec. 907. Performance standards.

‘‘Sec. 908. Notification and other remedies

‘‘Sec. 909. Records and reports on tobacco products.

‘‘Sec. 910. Premarket review of certain tobacco products.

‘‘Sec. 911. Judicial review.

‘‘Sec. 912. Postmarket surveillance

‘‘Sec. 913. Reduced risk tobacco products.

‘‘Sec. 914. Equal treatment of retail outlets.

‘‘Sec. 915. Jurisdiction of and coordination with the Federal Trade Commission.

‘‘Sec. 916. Congressional review provisions.

‘‘Sec. 917. Regulation requirement.

‘‘Sec. 918. Preservation of State and local authority.

Sec. 102. Construction of current regulations.

Sec. 103. Conforming and other amendments to general provisions.

TITLE II—TOBACCO PRODUCT WARNINGS AND SMOKE

CONSTITUENT DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.

Sec. 202. Authority to revise cigarette warning label Statements.

Sec. 203. Smokeless tobacco labels and advertising warnings.

Sec. 204. Authority to revise smokeless tobacco product warning label Statements.

Sec. 205. Tar, nicotine, and other smoke constituent disclosure to the public.

Sec. 206. Unlawful advertisements.

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 and worsening

5 proportions that results in new generations of to6 bacco-dependent children and adults.
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1 (2) A consensus exists within the scientific and

2 medical communities that tobacco products are in3 herently dangerous and cause cancer, heart disease,

4 and other serious adverse health effects.

5 (3) Nicotine is an addictive drug.

6 (4) Virtually all new users of tobacco products

7 are under the minimum legal age to purchase such

8 products.

9 (5) Tobacco advertising and marketing con10 tribute significantly to the use of nicotine-containing

11 tobacco products by adolescents.

12 (6) Because past efforts to restrict advertising

13 and marketing of tobacco products have failed ade14 quately to curb tobacco use by adolescents, com15 prehensive restrictions on the sale, promotion, and

16 distribution of such products are needed.

17 (7) Federal and State governments have lacked

18 the legal and regulatory authority and resources

19 they need to address comprehensively the public

20 health and societal problems caused by the use of to21 bacco products.

22 (8) Federal and State public health officials,

23 the public health community, and the public at large

24 recognize that the tobacco industry should be subject

25 to ongoing oversight.
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1 (9) Under Article I, Section 8 of the Constitu2 tion, the Congress is vested with the responsibility

3 for regulating interstate commerce and commerce

4 with Indian tribes.

5 (10) The sale, distribution, marketing, adver6 tising, and use of tobacco products are activities in

7 and substantially affecting interstate commerce be8 cause they are sold, marketed, advertised, and dis9 tributed in interstate commerce on a nationwide

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

11 economy.

12 (11) The sale, distribution, marketing, adver13 tising, and use of such products substantially affect

14 interstate commerce through the health care and

15 other costs attributable to the use of tobacco prod16 ucts.

17 (12) The citizens of the several States are ex18 posed to, and adversely affected by, environmental

19 smoke in public buildings and other facilities which

20 imposes a burden on interstate commerce.

21 (13) It is in the public interest for Congress to

22 adopt legislation that provides the Food and Drug

23 Administration with the authority to regulate to24 bacco products because of tobacco’s unique position

25 in the Nation’s history and economy; the need to
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1 prevent the sale, distribution, marketing and adver2 tising of tobacco products to persons under the min3 imum legal age to purchase such products; and the

4 need to educate the public, especially young people,

5 regarding the health effects of using tobacco prod6 ucts.

7 (14) Public health authorities estimate that the

8 benefits to the Nation of enacting Federal legislation

9 to accomplish these goals would be significant in

10 human and economic terms.

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

12 50 percent would prevent well over 60,000 early

13 deaths each year and save up to $43,000,000,000

14 each year in reduced medical costs, improved pro15 ductivity, and the avoidance of premature deaths.

16 (16) Advertising, marketing, and promotion of

17 tobacco products have been especially directed to at18 tract young persons to use tobacco products and

19 these efforts have resulted in increased use of such

20 products by youth. Past efforts to oversee these ac21 tivities have not been successful in adequately pre22 venting such increased use.

23 (17) In 1995, the tobacco industry spent close

24 to $4,900,000,000 to attract new users, retain cur25 rent users, increase current consumption, and gen-
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1 erate favorable long-term attitudes toward smoking

2 and tobacco use.

3 (18) Tobacco product advertising often

4 misleadingly portrays the use of tobacco as socially

5 acceptable and healthful to minors.

6 (19) Tobacco product advertising is regularly

7 seen by persons under the age of 18, and persons

8 under the age of 18 are regularly exposed to tobacco

9 product promotional efforts.

10 (20) Through advertisements during and spon11 sorship of sporting events, tobacco has become

12 strongly associated with sports and has become por13 trayed as an integral part of sports and the healthy

14 lifestyle associated with rigorous sporting activity.

15 (21) Children are exposed to substantial and

16 unavoidable tobacco advertising that leads to favor17 able beliefs about tobacco use, plays a role in leading

18 young people to overestimate the prevalence of to19 bacco use, and increases the number of young people

20 who begin to use tobacco.

21 (22) Tobacco advertising increases the size of

22 the tobacco market by increasing consumption of to23 bacco products including increasing tobacco use by

24 young people.
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1 (23) Children are more influenced by tobacco

2 advertising than adults, they smoke the most adver3 tised brands, and children as young as 3 to 6 years

4 old can recognize a character associated with smok5 ing at the same rate as they recognize cartoons and

6 fast food characters.

7 (24) Tobacco company documents indicate that

8 young people are an important and often crucial seg9 ment of the tobacco market.

10 (25) Comprehensive advertising restrictions will

11 have a positive effect on the smoking rates of young

12 people.

13 (26) Restrictions on advertising are necessary

14 to prevent unrestricted tobacco advertising from un15 dermining legislation prohibiting access to young

16 people and providing for education about tobacco

17 use.

18 (27) International experience shows that adver19 tising regulations that are stringent and comprehen20 sive have a greater impact on overall tobacco use

21 and young people’s use than weaker or less com22 prehensive ones. Text-only requirements, while not

23 as stringent as a ban, will help reduce underage use

24 of tobacco products while preserving the informa25 tional function of advertising.
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1 (28) It is in the public interest for Congress to

2 adopt legislation to address the public health crisis

3 created by actions of the tobacco industry.

4 (29) The use of tobacco products in motion pic5 tures and other mass media glamorizes its use for

6 young people and encourages them to use tobacco

7 products.

8 SEC. 3. PURPOSE.

9 The purposes of this Act are—

10 (1) to provide authority to the Food and Drug

11 Administration to regulate tobacco products under

12 the Federal Food, Drug, and Cosmetic Act (21

13 U.S.C. 301 et seq.), by recognizing it as the primary

14 Federal regulatory authority with respect to the

15 manufacture, marketing, and distribution of tobacco

16 products;

17 (2) to ensure that the Food and Drug Adminis18 tration has the authority to address issues of par19 ticular concern to public health officials, especially

20 the use of tobacco by young people and dependence

21 on tobacco;

22 (3) to authorize the Food and Drug Adminis23 tration to set national standards controlling the

24 manufacture of tobacco products and the identity,
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1 public disclosure, and amount of ingredients used in

2 such products;

3 (4) to provide new and flexible enforcement au4 thority to ensure that there is effective oversight of

5 the tobacco industry’s efforts to develop and intro6 duce less harmful tobacco products;

7 (5) to vest the Food and Drug Administration

8 with the authority to regulate the levels of tar, nico9 tine, and other harmful components of tobacco prod10 ucts;

11 (6) in order to ensure that adults are better in12 formed, to require tobacco product manufacturers to

13 disclose research which has not previously been

14 made available, as well as research generated in the

15 future, relating to the health and dependency effects

16 or safety of tobacco products;

17 (7) to continue to permit the sale of tobacco

18 products to adults in conjunction with measures to

19 ensure that they are not sold or accessible to under20 age purchasers; and

21 (8) to impose appropriate regulatory controls on

22 the tobacco industry

23 SEC. 4. SCOPE AND EFFECT.

24 (a) INTENDED EFFECT.—Nothing in this Act (or an

25 amendment made by this Act) shall be construed to—
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1 (1) establish a precedent with regard to any

2 other industry, situation, circumstance, or legal ac3 tion; or

4 (2) affect any action pending in State, Tribal,

5 or Federal court, or any agreement, consent decree,

6 or contract of any kind.

7 (b) AGRICULTURAL ACTIVITIES.—The provisions of

8 this Act (or an amendment made by this Act) which au9 thorize the Secretary to take certain actions with regard

10 to tobacco and tobacco products shall not be construed to

11 affect any authority of the Secretary of Agriculture under

12 existing law regarding the growing, cultivation, or curing

13 of raw tobacco.

14 TITLE I—AUTHORITY OF THE

15 FOOD AND DRUG ADMINIS16 TRATION

17 SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND

18 COSMETIC ACT.

19 (a) DEFINITION OF TOBACCO PRODUCTS.—Section

20 201 of the Federal Food, Drug, and Cosmetic Act (21

21 U.S.C. 321) is amended by adding at the end the fol22 lowing:

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

24 product made or derived from tobacco that is in25 tended for human consumption, including any com-
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1 ponent, part, or accessory of a tobacco product (ex2 cept for raw materials other than tobacco used in

3 manufacturing a component, part, or accessory of a

4 tobacco product).’’.

5 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

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

7 301 et seq.) is amended—

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

9 (2) by redesignating sections 901 through 907

10 as sections 1001 through 1007; and

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

12 ‘‘CHAPTER IX—TOBACCO

13 PRODUCTS

14 ‘‘SEC. 900. DEFINITIONS.

15 ‘‘In this chapter:

16 ‘‘(1) BRAND.—The term ‘brand’ means a vari17 ety of tobacco product distinguished by the tobacco

18 used, tar content, nicotine content, flavoring used,

19 size, filtration, or packaging, logo, registered trade20 mark or brand name, identifiable pattern of colors,

21 or any combination of such attributes.

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

23 meaning given that term by section 3(1) of the Fed24 eral Cigarette Labeling and Advertising Act (15

25 U.S.C. 1332(1)), but also includes tobacco, in any
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1 form, that is functional in the product, which, be2 cause of its appearance, the type of tobacco used in

3 the filler, or its packaging and labeling, is likely to

4 be offered to, or purchased by, consumers as a ciga5 rette or as roll-your-own tobacco.

6 ‘‘(3) CIGARETTE TOBACCO.—The term ‘ciga7 rette tobacco’ means any product that consists of

8 loose tobacco that is intended for use by consumers

9 in a cigarette. Unless otherwise stated, the require10 ments for cigarettes shall also apply to cigarette to11 bacco.

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

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

14 Federal Cigarette Labeling and Advertising Act (15

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

16 ‘‘(5) DISTRIBUTOR.—The term ‘distributor’ as

17 regards a tobacco product means any person who

18 furthers the distribution of cigarette or smokeless to19 bacco, whether domestic or imported, at any point

20 from the original place of manufacture to the person

21 who sells or distributes the product to individuals for

22 personal consumption. Common carriers are not con23 sidered distributors for purposes of this chapter.

24 ‘‘(6) INDIAN TRIBE.—The term ‘Indian tribe’

25 has the meaning given such term in section 4(e) of
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1 the Indian Self Determination and Education Assist2 ance Act (25 U.S.C. 450b(e)).

3 ‘‘(7) LITTLE CIGAR.—The term ‘little cigar’ has

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

5 Federal Cigarette Labeling and Advertising Act (15

6 U.S.C. 1332(7)).

7 ‘‘(8) NICOTINE.—The term ‘nicotine’ means the

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

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

10 any salt or complex of nicotine.

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

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

13 other container, any wrapping (including cello14 phane), in which cigarettes or smokeless tobacco are

15 offered for sale, sold, or otherwise distributed to con16 sumers.

17 ‘‘(10) RETAILER.—The term ‘retailer’ means

18 any person who sells cigarettes or smokeless tobacco

19 to individuals for personal consumption, or who op20 erates a facility where self-service displays of tobacco

21 products are permitted.

22 ‘‘(11) ROLL-YOUR-OWN TOBACCO.—The term

23 ‘roll-your-own tobacco’ means any tobacco which, be24 cause of its appearance, type, packaging, or labeling,

25 is suitable for use and likely to be offered to, or pur-
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1 chased by, consumers as tobacco for making ciga2 rettes.

3 ‘‘(12) SMOKELESS TOBACCO.—The term

4 ‘smokeless tobacco’ means any product that consists

5 of cut, ground, powdered, or leaf tobacco and that

6 is intended to be placed in the oral or nasal cavity.

7 ‘‘(13) STATE.—The term ‘State’ means any

8 State of the United States and, for purposes of this

9 chapter, includes the District of Columbia, the Com10 monwealth of Puerto Rico, Guam, the Virgin Is11 lands, American Samoa, Wake Island, Midway Is12 lands, Kingman Reef, Johnston Atoll, the Northern

13 Mariana Islands, and any other trust territory or

14 possession of the United States.

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

16 product’ means cigarettes, cigarette tobacco, smoke17 less tobacco, little cigars, roll-your-own tobacco, and

18 fine cut products.

19 ‘‘(15) TOBACCO PRODUCT MANUFACTURER.—

20 Term ‘tobacco product manufacturer’ means any

21 person, including any repacker or relabeler, who—

22 ‘‘(A) manufactures, fabricates, assembles,

23 processes, or labels a finished cigarette or

24 smokeless tobacco product; or
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1 ‘‘(B) imports a finished cigarette or

2 smokeless tobacco product for sale or distribu3 tion in the United States.

4 ‘‘(16) UNITED STATES.—The term ‘United

5 States’ means the 50 States of the United States of

6 America and the District of Columbia, the Common7 wealth of Puerto Rico, Guam, the Virgin Islands,

8 American Samoa, Wake Island, Midway Islands,

9 Kingman Reef, Johnston Atoll, the Northern Mar10 iana Islands, and any other trust territory or posses11 sion of the United States.

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

13 ‘‘(a) IN GENERAL.—Tobacco products shall be regu14 lated by the Secretary under this chapter and shall not

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

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

17 diagnosis, cure, mitigation, treatment, or prevention

18 of disease (within the meaning of section

19 201(g)(1)(B) or section 201(h)(2)); or

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

21 under section 201(g)(1)(C) or 201(h)(3).

22 ‘‘(b) APPLICABILITY.—This chapter shall apply to all

23 tobacco products subject to the provisions of part 897 of

24 title 21, Code of Federal Regulations, and to any other
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1 tobacco products that the Secretary by regulation deems

2 to be subject to this chapter.

3 ‘‘(c) SCOPE.—

4 ‘‘(1) IN GENERAL.—Nothing in this chapter, or

5 any policy issued or regulation promulgated there6 under, or the Youth Smoking Prevention and Public

7 Health Protection Act, shall be construed to affect

8 the Secretary’s authority over, or the regulation of,

9 products under this Act that are not tobacco prod10 ucts under chapter V or any other chapter.

11 ‘‘(2) TOBACCO LEAF.—

12 ‘‘(A) IN GENERAL.—The provisions of this

13 chapter shall not apply to tobacco leaf that is

14 not in the possession of the manufacturer, or to

15 the producers of tobacco leaf, including tobacco

16 growers, tobacco warehouses, and tobacco grow17 er cooperatives, nor shall any employee of the

18 Food and Drug Administration have any au19 thority to enter onto a farm owned by a pro20 ducer of tobacco leaf without the written con21 sent of such producer.

22 ‘‘(B) EXCEPTION.—Notwithstanding any

23 other provision of this subparagraph, if a pro24 ducer of tobacco leaf is also a tobacco product

25 manufacturer or controlled by a tobacco prod-
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1 uct manufacturer, the producer shall be subject

2 to this chapter in the producer’s capacity as a

3 manufacturer.

4 ‘‘(C) RULE OF CONSTRUCTION.—Nothing

5 in this chapter shall be construed to grant the

6 Secretary authority to promulgate regulations

7 on any matter that involves the production of

8 tobacco leaf or a producer thereof, other than

9 activities by a manufacturer affecting produc10 tion. For purposes of the preceding sentence,

11 the term ‘controlled by’ means a member of the

12 same controlled group of corporations as that

13 term is used in section 52(a) of the Internal

14 Revenue Code of 1986, or under common con15 trol within the meaning of the regulations pro16 mulgated under section 52(b) of such Code.

17 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.

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

19 if—

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

21 putrid, or decomposed substance, or is otherwise

22 contaminated by any poisonous or deleterious sub23 stance that may render the product injurious to

24 health;
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1 ‘‘(2) it has been prepared, packed, or held

2 under insanitary conditions whereby it may have

3 been contaminated with filth, or whereby it may

4 have been rendered injurious to health;

5 ‘‘(3) its container is composed, in whole or in

6 part, of any poisonous or deleterious substance

7 which may render the contents injurious to health;

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

9 as, a tobacco product which is subject to a perform10 ance standard established under section 907 unless

11 such tobacco product is in all respects in conformity

12 with such standard;

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

14 premarket approval, is not exempt under section

15 906(f), and does not have an approved application in

16 effect;

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

18 controls used for, its manufacture, packing or stor19 age are not in conformity with applicable require20 ments under section 906(e)(1) or an applicable con21 dition prescribed by an order under section

22 906(e)(2); or

23 ‘‘(7) it is a tobacco product for which an ex24 emption has been granted under section 906(f) for

25 investigational use and the person who was granted
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1 such exemption or any investigator who uses such

2 tobacco product under such exemption fails to com3 ply with a requirement prescribed by or under such

4 section.

5 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.

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

7 deemed to be misbranded—

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

9 particular;

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

11 containing—

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

13 tobacco product manufacturer, packer, or dis14 tributor; and

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

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

17 numerical count,

18 except that under subparagraph (B) reasonable vari19 ations shall be permitted, and exemptions as to

20 small packages shall be established, by regulations

21 prescribed by the Secretary;

22 ‘‘(3) if any word, statement, or other informa23 tion required by or under authority of this chapter

24 to appear on the label or labeling is not prominently

25 placed thereon with such conspicuousness (as com-
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1 pared with other words, statements or designs in the

2 labeling) and in such terms as to render it likely to

3 be read and understood by the ordinary individual

4 under customary conditions of purchase and use;

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

6 label bears, to the exclusion of any other nonpropri7 etary name, its established name prominently print8 ed in type as required by the Secretary by regula9 tion;

10 ‘‘(5) if the Secretary has issued regulations re11 quiring that its labeling bear adequate directions for

12 use, or adequate warnings against use by children,

13 that are necessary for the protection of users unless

14 its labeling conforms in all respects to such regula15 tions;

16 ‘‘(6) if it was manufactured, prepared, propa17 gated, compounded, or processed in any State in an

18 establishment not duly registered under section

19 905(b), if it was not included in a list required by

20 section 905(i), if a notice or other information re21 specting it was not provided as required by such sec22 tion or section 905(j), or if it does not bear such

23 symbols from the uniform system for identification

24 of tobacco products prescribed under section 905(e)

25 as the Secretary by regulation requires;
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1 ‘‘(7) if, in the case of any tobacco product dis2 tributed or offered for sale in any State—

3 ‘‘(A) its advertising is false or misleading

4 in any particular; or

5 ‘‘(B) it is sold, distributed, or used in vio6 lation of regulations prescribed under section

7 906(d);

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

9 distributed or offered for sale in any State, the man10 ufacturer, packer, or distributor thereof includes in

11 all advertisements and other descriptive printed mat12 ter issued or caused to be issued by the manufac13 turer, packer, or distributor with respect to that to14 bacco product—

15 ‘‘(A) a true statement of the tobacco prod16 uct’s established name as defined in paragraph

17 (4), printed prominently; and

18 ‘‘(B) a brief statement of—

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

20 and relevant warnings, precautions, side

21 effects, and contraindications; and

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

23 products made subject to a finding by the

24 Secretary after notice and opportunity for

25 comment that such action is necessary to
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1 protect the public health, a full description

2 of the components of such tobacco product

3 or the formula showing quantitatively each

4 ingredient of such tobacco product to the

5 extent required in regulations which shall

6 be issued by the Secretary after an oppor7 tunity for a hearing;

8 ‘‘(9) if it is a tobacco product subject to a per9 formance standard established under section 907,

10 unless it bears such labeling as may be prescribed in

11 such performance standard; or

12 ‘‘(10) if there was a failure or refusal—

13 ‘‘(A) to comply with any requirement pre14 scribed under section 904 or 908;

15 ‘‘(B) to furnish any material or informa16 tion required by or under section 909; or

17 ‘‘(C) to comply with a requirement under

18 section 912.

19 ‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.—

20 The Secretary may, by regulation, require prior approval

21 of statements made on the label of a tobacco product. No

22 regulation issued under this subsection may require prior

23 approval by the Secretary of the content of any advertise24 ment. No advertisement of a tobacco product, published

25 after the date of enactment of the Youth Smoking Preven-
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1 tion and Public Health Protection Act shall, with respect

2 to the language of label statements as prescribed under

3 section 4 of the Cigarette Labeling and Advertising Act

4 and section 3 of the Comprehensive Smokeless Tobacco

5 Health Education Act of 1986 or the regulations issued

6 under such sections, be subject to the provisions of sec7 tions 12 through 15 of the Federal Trade Commission Act

8 (15 U.S.C. 52 through 55).

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 the Youth Smoking Prevention

13 and Public Health Protection Act, each tobacco product

14 manufacturer or importer of tobacco products, or agents

15 thereof, shall submit to the Secretary the following infor16 mation:

17 ‘‘(1) A listing of all tobacco ingredients, sub18 stances and compounds that are, on such date,

19 added by the manufacturer to the tobacco, paper, fil20 ter, or other component of each tobacco product by

21 brand and by quantity in each brand and subbrand.

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

23 form of nicotine in each tobacco product measured

24 in milligrams of nicotine.
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1 ‘‘(3) All documents (including underlying sci2 entific information) relating to research activities,

3 and research findings, conducted, supported, or pos4 sessed by the manufacturer (or agents thereof) on

5 the health, behavioral, or physiologic effects of to6 bacco products, their constituents, ingredients, and

7 components, and tobacco additives, described in

8 paragraph (1).

9 ‘‘(4) All documents (including underlying sci10 entific information) relating to research activities,

11 and research findings, conducted, supported, or pos12 sessed by the manufacturer (or agents thereof) that

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

14 health from tobacco products can occur upon the

15 employment of technology available or known to the

16 manufacturer.

17 ‘‘(5) All documents (including underlying sci18 entific information) relating to marketing research

19 involving the use of tobacco products.

20 An importer of a tobacco product not manufactured in the

21 United States shall supply the information required of a

22 tobacco product manufacturer under this subsection.

23 ‘‘(b) ANNUAL SUBMISSION.—A tobacco product man24 ufacturer or importer that is required to submit informa25 tion under subsection (a) shall update such information
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1 on an annual basis under a schedule determined by the

2 Secretary.

3 ‘‘(c) TIME FOR SUBMISSION.—

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

5 to the delivery for introduction into interstate com6 merce of a tobacco product not on the market on the

7 date of enactment of the Youth Smoking Prevention

8 and Public Health Protection Act, the manufacturer

9 of such product shall provide the information re10 quired under subsection (a) and such product shall

11 be subject to the annual submission under sub12 section (b).

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

14 If at any time a tobacco product manufacturer adds

15 to its tobacco products a new tobacco additive, in16 creases or decreases the quantity of an existing to17 bacco additive or the nicotine content, delivery, or

18 form, or eliminates a tobacco additive from any to19 bacco product, the manufacturer shall within 60

20 days of such action so advise the Secretary in writ21 ing and reference such modification in submissions

22 made under subsection (b).

23 ‘‘SEC. 905. ANNUAL REGISTRATION.

24 ‘‘(a) DEFINITIONS.—In this section:
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1 ‘‘(1) MANUFACTURE, PREPARATION,

2 COMPOUNDING, OR PROCESSING.—The term ‘manu3 facture, preparation, compounding, or processing’

4 shall include repackaging or otherwise changing the

5 container, wrapper, or labeling of any tobacco prod6 uct package in furtherance of the distribution of the

7 tobacco product from the original place of manufac8 ture to the person who makes final delivery or sale

9 to the ultimate consumer or user.

10 ‘‘(2) NAME.—The term ‘name’ shall include in

11 the case of a partnership the name of each partner

12 and, in the case of a corporation, the name of each

13 corporate officer and director, and the State of in14 corporation.

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

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

17 owns or operates any establishment in any State engaged

18 in the manufacture, preparation, compounding, or proc19 essing of a tobacco product or tobacco products shall reg20 ister with the Secretary the name, places of business, and

21 all such establishments of that person.

22 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA23 TORS.—Every person upon first engaging in the manufac24 ture, preparation, compounding, or processing of a tobacco

25 product or tobacco products in any establishment owned
27

•S 2568 IS

1 or operated in any State by that person shall immediately

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

3 business, and such establishment.

4 ‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.—

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

6 (c) shall immediately register with the Secretary any addi7 tional establishment which that person owns or operates

8 in any State and in which that person begins the manufac9 ture, preparation, compounding, or processing of a tobacco

10 product or tobacco products.

11 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS12 TEM.—The Secretary may by regulation prescribe a uni13 form system for the identification of tobacco products and

14 may require that persons who are required to list such

15 tobacco products under subsection (i) shall list such to16 bacco products in accordance with such system.

17 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA18 TION.—The Secretary shall make available for inspection,

19 to any person so requesting, any registration filed under

20 this section.

21 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB22 LISHMENTS.—Every establishment in any State registered

23 with the Secretary under this section shall be subject to

24 inspection under section 704, and every such establish25 ment engaged in the manufacture, compounding, or proc-
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•S 2568 IS

1 essing of a tobacco product or tobacco products shall be

2 so inspected by one or more officers or employees duly

3 designated by the Secretary at least once in the 2-year

4 period beginning with the date of registration of such es5 tablishment under this section and at least once in every

6 successive 2-year period thereafter.

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

8 Any establishment within any foreign country engaged in

9 the manufacture, preparation, compounding, or processing

10 of a tobacco product or tobacco products, may register

11 under this section under regulations promulgated by the

12 Secretary. Such regulations shall require such establish13 ment to provide the information required by subsection (i)

14 of this section and shall include provisions for registration

15 of any such establishment upon condition that adequate

16 and effective means are available, by arrangement with the

17 government of such foreign country or otherwise, to enable

18 the Secretary to determine from time to time whether to19 bacco products manufactured, prepared, compounded, or

20 processed in such establishment, if imported or offered for

21 import into the United States, shall be refused admission

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

23 ‘‘(i) REGISTRATION INFORMATION.—

24 ‘‘(1) PRODUCT LIST.—Every person who reg25 isters with the Secretary under subsection (b), (c),
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•S 2568 IS

1 or (d) shall, at the time of registration under any

2 such subsection, file with the Secretary a list of all

3 tobacco products which are being manufactured, pre4 pared, compounded, or processed by that person for

5 commercial distribution and which has not been in6 cluded in any list of tobacco products filed by that

7 person with the Secretary under this paragraph or

8 paragraph (2) before such time of registration. Such

9 list shall be prepared in such form and manner as

10 the Secretary may prescribe and shall be accom11 panied by—

12 ‘‘(A) in the case of a tobacco product con13 tained in the applicable list with respect to

14 which a performance standard has been estab15 lished under section 907 or which is subject to

16 section 910, a reference to the authority for the

17 marketing of such tobacco product and a copy

18 of all labeling for such tobacco product;

19 ‘‘(B) in the case of any other tobacco prod20 uct contained in an applicable list, a copy of all

21 consumer information and other labeling for

22 such tobacco product, a representative sampling

23 of advertisements for such tobacco product,

24 and, upon request made by the Secretary for
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•S 2568 IS

1 good cause, a copy of all advertisements for a

2 particular tobacco product; and

3 ‘‘(C) if the registrant filing a list has de4 termined that a tobacco product contained in

5 such list is not subject to a performance stand6 ard established under section 907, a brief state7 ment of the basis upon which the registrant

8 made such determination if the Secretary re9 quests such a statement with respect to that

10 particular tobacco product.

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

12 PRODUCT LIST.—Each person who registers with the

13 Secretary under this section shall report to the Sec14 retary once during the month of June of each year

15 and once during the month of December of each

16 year the following:

17 ‘‘(A) A list of each tobacco product intro18 duced by the registrant for commercial distribu19 tion which has not been included in any list

20 previously filed by that person with the Sec21 retary under this subparagraph or paragraph

22 (1). A list under this subparagraph shall list a

23 tobacco product by its established name and

24 shall be accompanied by the other information

25 required by paragraph (1).
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•S 2568 IS

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

2 made a report under this paragraph that person

3 has discontinued the manufacture, preparation,

4 compounding, or processing for commercial dis5 tribution of a tobacco product included in a list

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

7 notice of such discontinuance, the date of such

8 discontinuance, and the identity of its estab9 lished name.

10 ‘‘(C) If since the date the registrant re11 ported under subparagraph (B) a notice of dis12 continuance that person has resumed the manu13 facture, preparation, compounding, or proc14 essing for commercial distribution of the to15 bacco product with respect to which such notice

16 of discontinuance was reported, notice of such

17 resumption, the date of such resumption, the

18 identity of such tobacco product by established

19 name, and other information required by para20 graph (1), unless the registrant has previously

21 reported such resumption to the Secretary

22 under this subparagraph.

23 ‘‘(D) Any material change in any informa24 tion previously submitted under this paragraph

25 or paragraph (1).
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•S 2568 IS

1 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER2 TAIN SUBSTANTIALLY-EQUIVALENT PRODUCTS INTO

3 INTERSTATE COMMERCE.—

4 ‘‘(1) IN GENERAL.—Each person who is re5 quired to register under this section and who pro6 poses to begin the introduction or delivery for intro7 duction into interstate commerce for commercial dis8 tribution of a tobacco product intended for human

9 use that was not commercially marketed (other than

10 for test marketing) in the United States as of Au11 gust 11, 1995, as defined by the Secretary by regu12 lation shall, at least 90 days before making such in13 troduction or delivery, report to the Secretary (in

14 such form and manner as the Secretary shall by reg15 ulation prescribe)—

16 ‘‘(A) the basis for such person’s determina17 tion that the tobacco product is substantially

18 equivalent, within the meaning of section 910,

19 to a tobacco product commercially marketed

20 (other than for test marketing) in the United

21 States as of August 11, 1995, that is in compli22 ance with the requirements of this Act; and

23 ‘‘(B) action taken by such person to com24 ply with the requirements under section 907

25 that are applicable to the tobacco product.
33

•S 2568 IS

1 ‘‘(2) APPLICATION TO CERTAIN POST-AUGUST

2 11TH PRODUCTS.—A report under this subsection

3 for a tobacco product that was first introduced or

4 delivered for introduction into interstate commerce

5 for commercial distribution in the United States

6 after August 11, 1995, and before the date of enact7 ment of the Youth Smoking Prevention and Public

8 Health Protection Act shall be submitted to the Sec9 retary within 6 months after the date of enactment

10 of that Act.

11 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL

12 OF TOBACCO PRODUCTS.

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

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

15 tobacco product shall apply to such tobacco product until

16 the applicability of the requirement to the tobacco product

17 has been changed by action taken under section 907, sec18 tion 910, or subsection (d) of this section, and any re19 quirement established by or under section 902, 903, 905,

20 or 909 which is inconsistent with a requirement imposed

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

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

23 tobacco product.

24 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM25 MENT.—Each notice of proposed rulemaking under section
34

•S 2568 IS

1 907, 908, 909, or 910, or under this section, any other

2 notice which is published in the Federal Register with re3 spect to any other action taken under any such section

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

5 publication of findings required to be made in connection

6 with rulemaking under any such section shall set forth—

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

8 may examine data and other information on which

9 the notice or findings is based; and

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

11 may present their comments on the notice or find12 ings (including the need therefore) orally or in writ13 ing, which period shall be at least 60 days but may

14 not exceed 90 days unless the time is extended by

15 the Secretary by a notice published in the Federal

16 Register stating good cause therefore.

17 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA18 TION.—Any information reported to or otherwise obtained

19 by the Secretary or the Secretary’s representative under

20 section 904, 907, 908, 909, or 910 or 704, or under sub21 section (e) or (f) of this section, which is exempt from

22 disclosure under subsection (a) of section 552 of title 5,

23 United States Code, by reason of subsection (b)(4) of that

24 section shall be considered confidential and shall not be

25 disclosed, except that the information may be disclosed to
35

•S 2568 IS

1 other officers or employees concerned with carrying out

2 this chapter, or when relevant in any proceeding under

3 this chapter.

4 ‘‘(d) RESTRICTIONS.—

5 ‘‘(1) IN GENERAL.—The Secretary may by reg6 ulation require that a tobacco product be restricted

7 to sale, distribution, or use upon such conditions, in8 cluding restrictions on the access to, and the adver9 tising and promotion of, the tobacco product, as the

10 Secretary may prescribe in such regulation if, be11 cause of its potentiality for harmful effect or the col12 lateral measures necessary to its use, the Secretary

13 determines that such regulation would be appro14 priate for the protection of the public health. The

15 finding as to whether such regulation would be ap16 propriate for the protection of the public health shall

17 be determined with respect to the risks and benefits

18 to the population as a whole, including users and

19 non-users of the tobacco product, and taking into

20 account—

21 ‘‘(A) the increased or decreased likelihood

22 that existing users of tobacco products will stop

23 using such products; and
36

•S 2568 IS

1 ‘‘(B) the increased or decreased likelihood

2 that those who do not use tobacco products will

3 start using such products.

4 No such condition may require that the sale or dis5 tribution of a tobacco product be limited to the writ6 ten or oral authorization of a practitioner licensed

7 by law to prescribe medical products.

8 ‘‘(2) LABEL STATEMENTS.—The label of a to9 bacco product shall bear such appropriate state10 ments of the restrictions required by a regulation

11 under subsection (a) as the Secretary may in such

12 regulation prescribe.

13 ‘‘(3) LIMITATION.—No restriction under para14 graph (1) may prohibit the sale of any tobacco prod15 uct in face-to face transactions by a specific category

16 of retail outlets.

17 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE18 MENTS.—

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

20 CONFORM.—

21 ‘‘(A) IN GENERAL.—The Secretary may, in

22 accordance with subparagraph (B), prescribe

23 regulations requiring that the methods used in,

24 and the facilities and controls used for, the

25 manufacture, pre-production design validation
37

•S 2568 IS

1 (including a process to assess the performance

2 of a tobacco product), packing and storage of a

3 tobacco product, conform to current good man4 ufacturing practice, as prescribed in such regu5 lations, to assure that the public health is pro6 tected and that the tobacco product is in com7 pliance with this chapter.

8 ‘‘(B) REQUIREMENTS.—The Secretary

9 shall—

10 ‘‘(i) before promulgating any regula11 tion under subparagraph (A), afford an ad12 visory committee an opportunity to submit

13 recommendations with respect to the regu14 lation proposed to be promulgated;

15 ‘‘(ii) before promulgating any regula16 tion under subparagraph (A), afford oppor17 tunity for an oral hearing;

18 ‘‘(iii) provide the advisory committee a

19 reasonable time to make its recommenda20 tion with respect to proposed regulations

21 under subparagraph (A); and

22 ‘‘(iv) in establishing the effective date

23 of a regulation promulgated under this

24 subsection, take into account the dif25 ferences in the manner in which the dif-
38

•S 2568 IS

1 ferent types of tobacco products have his2 torically been produced, the financial re3 sources of the different tobacco product

4 manufacturers, and the state of their exist5 ing manufacturing facilities, and shall pro6 vide for a reasonable period of time for

7 such manufacturers to conform to good

8 manufacturing practices.

9 ‘‘(2) EXEMPTIONS; VARIANCES.—

10 ‘‘(A) PETITION.—Any person subject to

11 any requirement prescribed under paragraph

12 (1) may petition the Secretary for a permanent

13 or temporary exemption or variance from such

14 requirement. Such a petition shall be submitted

15 to the Secretary in such form and manner as

16 the Secretary shall prescribe and shall—

17 ‘‘(i) in the case of a petition for an ex18 emption from a requirement, set forth the

19 basis for the petitioner’s determination

20 that compliance with the requirement is

21 not required to assure that the tobacco

22 product will be in compliance with this

23 chapter;

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

25 variance from a requirement, set forth the
39

•S 2568 IS

1 methods proposed to be used in, and the

2 facilities and controls proposed to be used

3 for, the manufacture, packing, and storage

4 of the tobacco product in lieu of the meth5 ods, facilities, and controls prescribed by

6 the requirement; and

7 ‘‘(iii) contain such other information

8 as the Secretary shall prescribe.

9 ‘‘(B) REFERRAL TO ADVISORY COM10 MITTEE.—The Secretary may refer to an advi11 sory committee any petition submitted under

12 subparagraph (A). The advisory committee

13 shall report its recommendations to the Sec14 retary with respect to a petition referred to it

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

16 referral. Within 60 days after—

17 ‘‘(i) the date the petition was sub18 mitted to the Secretary under subpara19 graph (A); or

20 ‘‘(ii) the day after the petition was re21 ferred to an advisory committee,

22 whichever occurs later, the Secretary shall by

23 order either deny the petition or approve it.

24 ‘‘(C) APPROVAL.—The Secretary may

25 approve—
40

•S 2568 IS

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

2 tobacco product from a requirement if the

3 Secretary determines that compliance with

4 such requirement is not required to assure

5 that the tobacco product will be in compli6 ance with this chapter; and

7 ‘‘(ii) a petition for a variance for a to8 bacco product from a requirement if the

9 Secretary determines that the methods to

10 be used in, and the facilities and controls

11 to be used for, the manufacture, packing,

12 and storage of the tobacco product in lieu

13 of the methods, controls, and facilities pre14 scribed by the requirement are sufficient to

15 assure that the tobacco product will be in

16 compliance with this chapter.

17 ‘‘(D) CONDITIONS.—An order of the Sec18 retary approving a petition for a variance shall

19 prescribe such conditions respecting the meth20 ods used in, and the facilities and controls used

21 for, the manufacture, packing, and storage of

22 the tobacco product to be granted the variance

23 under the petition as may be necessary to as24 sure that the tobacco product will be in compli25 ance with this chapter.
41

•S 2568 IS

1 ‘‘(E) HEARING.—After the issuance of an

2 order under subparagraph (B) respecting a pe3 tition, the petitioner shall have an opportunity

4 for an informal hearing on such order.

5 ‘‘(3) COMPLIANCE.—Compliance with require6 ments under this subsection shall not be required be7 fore the period ending 3 years after the date of en8 actment of the Youth Smoking Prevention and Pub9 lic Health Protection Act.

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

11 Secretary may exempt tobacco products intended for in12 vestigational use from this chapter under such conditions

13 as the Secretary may prescribe by regulation.

14 ‘‘(g) RESEARCH AND DEVELOPMENT.—The Sec15 retary may enter into contracts for research, testing, and

16 demonstrations respecting tobacco products and may ob17 tain tobacco products for research, testing, and dem18 onstration purposes without regard to section 3324(a) and

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

20 41, United States Code.

21 ‘‘SEC. 907. PERFORMANCE STANDARDS.

22 ‘‘(a) IN GENERAL.—

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

24 adopt performance standards for a tobacco product

25 if the Secretary finds that a performance standard
42

•S 2568 IS

1 is appropriate for the protection of the public health.

2 This finding shall be determined with respect to the

3 risks and benefits to the population as a whole, in4 cluding users and non-users of the tobacco product,

5 and taking into account—

6 ‘‘(A) the increased or decreased likelihood

7 that existing users of tobacco products will stop

8 using such products; and

9 ‘‘(B) the increased or decreased likelihood

10 that those who do not use tobacco products will

11 start using such products.

12 ‘‘(2) CONTENT OF PERFORMANCE STAND13 ARDS.—A performance standard established under

14 this section for a tobacco product—

15 ‘‘(A) shall include provisions to provide

16 performance that is appropriate for the protec17 tion of the public health, including provisions,

18 where appropriate—

19 ‘‘(i) for the reduction or elimination of

20 nicotine yields of the product;

21 ‘‘(ii) for the reduction or elimination

22 of other constituents or harmful compo23 nents of the product; or

24 ‘‘(iii) relating to any other require25 ment under (B);
43

•S 2568 IS

1 ‘‘(B) shall, where necessary to be appro2 priate for the protection of the public health,

3 include—

4 ‘‘(i) provisions respecting the con5 struction, components, ingredients, and

6 properties of the tobacco product;

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

8 sample basis or, if necessary, on an indi9 vidual basis) of the tobacco product;

10 ‘‘(iii) provisions for the measurement

11 of the performance characteristics of the

12 tobacco product;

13 ‘‘(iv) provisions requiring that the re14 sults of each or of certain of the tests of

15 the tobacco product required to be made

16 under clause (ii) show that the tobacco

17 product is in conformity with the portions

18 of the standard for which the test or tests

19 were required; and

20 ‘‘(v) a provision requiring that the

21 sale and distribution of the tobacco prod22 uct be restricted but only to the extent

23 that the sale and distribution of a tobacco

24 product may be restricted under a regula25 tion under section 906(d); and
44

•S 2568 IS

1 ‘‘(C) shall, where appropriate, require the

2 use and prescribe the form and content of label3 ing for the proper use of the tobacco product.

4 ‘‘(3) PERIODIC RE-EVALUATION OF PERFORM5 ANCE STANDARDS.—The Secretary shall provide for

6 periodic evaluation of performance standards estab7 lished under this section to determine whether such

8 standards should be changed to reflect new medical,

9 scientific, or other technological data. The Secretary

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

11 person.

12 ‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN13 FORMED PERSONS.—In carrying out duties under

14 this section, the Secretary shall, to the maximum ex15 tent practicable—

16 ‘‘(A) use personnel, facilities, and other

17 technical support available in other Federal

18 agencies;

19 ‘‘(B) consult with other Federal agencies

20 concerned with standard-setting and other na21 tionally or internationally recognized standard22 setting entities; and

23 ‘‘(C) invite appropriate participation,

24 through joint or other conferences, workshops,

25 or other means, by informed persons represent-
45

•S 2568 IS

1 ative of scientific, professional, industry, or con2 sumer organizations who in the Secretary’s

3 judgment can make a significant contribution.

4 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

5 ‘‘(1) NOTICE.—

6 ‘‘(A) IN GENERAL.—The Secretary shall

7 publish in the Federal Register a notice of pro8 posed rulemaking for the establishment, amend9 ment, or revocation of any performance stand10 ard for a tobacco product.

11 ‘‘(B) REQUIREMENTS OF NOTICE.—A no12 tice of proposed rulemaking for the establish13 ment or amendment of a performance standard

14 for a tobacco product shall—

15 ‘‘(i) set forth a finding with sup16 porting justification that the performance

17 standard is appropriate for the protection

18 of the public health;

19 ‘‘(ii) set forth proposed findings with

20 respect to the risk of illness or injury that

21 the performance standard is intended to

22 reduce or eliminate; and

23 ‘‘(iii) invite interested persons to sub24 mit an existing performance standard for

25 the tobacco product, including a draft or
46

•S 2568 IS

1 proposed performance standard, for consid2 eration by the Secretary.

3 ‘‘(C) FINDING.—A notice of proposed rule4 making for the revocation of a performance

5 standard shall set forth a finding with sup6 porting justification that the performance

7 standard is no longer necessary to be appro8 priate for the protection of the public health.

9 ‘‘(D) CONSIDERATION BY SECRETARY.—

10 The Secretary shall consider all information

11 submitted in connection with a proposed stand12 ard, including information concerning the coun13 tervailing effects of the performance standard

14 on the health of adolescent tobacco users, adult

15 tobacco users, or non-tobacco users, such as the

16 creation of a significant demand for contraband

17 or other tobacco products that do not meet the

18 requirements of this chapter and the signifi19 cance of such demand, and shall issue the

20 standard if the Secretary determines that the

21 standard would be appropriate for the protec22 tion of the public health.

23 ‘‘(E) COMMENT.—The Secretary shall pro24 vide for a comment period of not less than 60

25 days.
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•S 2568 IS

1 ‘‘(2) PROMULGATION.—

2 ‘‘(A) IN GENERAL.—After the expiration of

3 the period for comment on a notice of proposed

4 rulemaking published under paragraph (1) re5 specting a performance standard and after con6 sideration of such comments and any report

7 from an advisory committee, the Secretary

8 shall—

9 ‘‘(i) promulgate a regulation estab10 lishing a performance standard and pub11 lish in the Federal Register findings on the

12 matters referred to in paragraph (1); or

13 ‘‘(ii) publish a notice terminating the

14 proceeding for the development of the

15 standard together with the reasons for

16 such termination.

17 ‘‘(B) EFFECTIVE DATE.—A regulation es18 tablishing a performance standard shall set

19 forth the date or dates upon which the standard

20 shall take effect, but no such regulation may

21 take effect before one year after the date of its

22 publication unless the Secretary determines

23 that an earlier effective date is necessary for

24 the protection of the public health. Such date or

25 dates shall be established so as to minimize,
48

•S 2568 IS

1 consistent with the public health, economic loss

2 to, and disruption or dislocation of, domestic

3 and international trade.

4 ‘‘(3) SPECIAL RULE FOR STANDARD BANNING

5 CLASS OF PRODUCT OR ELIMINATING NICOTINE CON6 TENT.—Because of the importance of a decision of

7 the Secretary to issue a regulation establishing a

8 performance standard—

9 ‘‘(A) eliminating all cigarettes, all smoke10 less tobacco products, or any similar class of to11 bacco products, or

12 ‘‘(B) requiring the reduction of nicotine

13 yields of a tobacco product to zero,

14 it is appropriate for the Congress to have the oppor15 tunity to review such a decision. Therefore, any such

16 standard may not take effect before a date that is

17 2 years after the President notifies the Congress

18 that a final regulation imposing the restriction has

19 been issued.

20 ‘‘(4) AMENDMENT; REVOCATION.—

21 ‘‘(A) AUTHORITY.—The Secretary, upon

22 the Secretary’s own initiative or upon petition

23 of an interested person may by a regulation,

24 promulgated in accordance with the require-
49

•S 2568 IS

1 ments of paragraphs (1) and (2)(B), amend or

2 revoke a performance standard.

3 ‘‘(B) EFFECTIVE DATE.—The Secretary

4 may declare a proposed amendment of a per5 formance standard to be effective on and after

6 its publication in the Federal Register and until

7 the effective date of any final action taken on

8 such amendment if the Secretary determines

9 that making it so effective is in the public inter10 est.

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

12 The Secretary—

13 ‘‘(A) may, on the Secretary’s own initia14 tive, refer a proposed regulation for the estab15 lishment, amendment, or revocation of a per16 formance standard; or

17 ‘‘(B) shall, upon the request of an inter18 ested person which demonstrates good cause for

19 referral and which is made before the expiration

20 of the period for submission of comments on

21 such proposed regulation,

22 refer such proposed regulation to an advisory committee,

23 for a report and recommendation with respect to any mat24 ter involved in the proposed regulation which requires the

25 exercise of scientific judgment. If a proposed regulation
50

•S 2568 IS

1 is referred under this paragraph to the advisory com2 mittee, the Secretary shall provide the advisory committee

3 with the data and information on which such proposed

4 regulation is based. The advisory committee shall, within

5 60 days after the referral of a proposed regulation and

6 after independent study of the data and information fur7 nished to it by the Secretary and other data and informa8 tion before it, submit to the Secretary a report and rec9 ommendation respecting such regulation, together with all

10 underlying data and information and a statement of the

11 reason or basis for the recommendation. A copy of such

12 report and recommendation shall be made public by the

13 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 an unreasonable

20 risk of substantial harm to the public health; and

21 ‘‘(2) notification under this subsection is nec22 essary to eliminate the unreasonable risk of such

23 harm and no more practicable means is available

24 under the provisions of this chapter (other than this

25 section) to eliminate such risk,
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•S 2568 IS

1 the Secretary may issue such order as may be necessary

2 to assure that adequate notification is provided in an ap3 propriate form, by the persons and means best suited

4 under the circumstances involved, to all persons who

5 should properly receive such notification in order to elimi6 nate such risk. The Secretary may order notification by

7 any appropriate means, including public service announce8 ments. Before issuing an order under this subsection, the

9 Secretary shall consult with the persons who are to give

10 notice under the order.

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

12 Compliance with an order issued under this section shall

13 not relieve any person from liability under Federal or

14 State law. In awarding damages for economic loss in an

15 action brought for the enforcement of any such liability,

16 the value to the plaintiff in such action of any remedy

17 provided under such order shall be taken into account.

18 ‘‘(c) RECALL AUTHORITY.—

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

20 there is a reasonable probability that a tobacco prod21 uct contains a manufacturing or other defect not or22 dinarily contained in tobacco products on the market

23 that would cause serious, adverse health con24 sequences or death, the Secretary shall issue an

25 order requiring the appropriate person (including
52

•S 2568 IS

1 the manufacturers, importers, distributors, or retail2 ers of the tobacco product) to immediately cease dis3 tribution of such tobacco product. The order shall

4 provide the person subject to the order with an op5 portunity for an informal hearing, to be held not

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

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

8 on whether the order should be amended to require

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

10 an opportunity for such a hearing, the Secretary de11 termines that inadequate grounds exist to support

12 the actions required by the order, the Secretary shall

13 vacate the order.

14 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE15 CALL.—

16 ‘‘(A) IN GENERAL.—If, after providing an

17 opportunity for an informal hearing under

18 paragraph (1), the Secretary determines that

19 the order should be amended to include a recall

20 of the tobacco product with respect to which the

21 order was issued, the Secretary shall, except as

22 provided in subparagraph (B), amend the order

23 to require a recall. The Secretary shall specify

24 a timetable in which the tobacco product recall

25 will occur and shall require periodic reports to
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1 the Secretary describing the progress of the re2 call.

3 ‘‘(B) NOTICE.—An amended order under

4 subparagraph (A)—

5 ‘‘(i) shall not include recall of a to6 bacco product from individuals; and

7 ‘‘(ii) shall provide for notice to per8 sons subject to the risks associated with

9 the use of such tobacco product.

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

11 the Secretary may use the assistance of retail12 ers and other persons who distributed such to13 bacco product. If a significant number of such

14 persons cannot be identified, the Secretary shall

15 notify such persons under section 705(b).

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

17 provided by this subsection shall be in addition to

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

19 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD20 UCTS.

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

22 product manufacturer or importer of a tobacco product

23 shall establish and maintain such records, make such re24 ports, and provide such information, as the Secretary may

25 by regulation reasonably require to assure that such to-
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1 bacco product is not adulterated or misbranded and to

2 otherwise protect public health. Regulations prescribed

3 under the preceding sentence—

4 ‘‘(1) may require a tobacco product manufac5 turer or importer to report to the Secretary when6 ever the manufacturer or importer receives or other7 wise becomes aware of information that reasonably

8 suggests that one of its marketed tobacco products

9 may have caused or contributed to a serious unex10 pected adverse experience associated with the use of

11 the product or any significant increase in the fre12 quency of a serious, expected adverse product experi13 ence;

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

15 adverse tobacco product experiences as determined

16 by the Secretary to be necessary to be reported;

17 ‘‘(3) shall not impose requirements unduly bur18 densome to a tobacco product manufacturer or im19 porter, taking into account the cost of complying

20 with such requirements and the need for the protec21 tion of the public health and the implementation of

22 this chapter;

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

24 requests for reports or information, shall require

25 that each request made under such regulations for
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1 submission of a report or information to the Sec2 retary state the reason or purpose for such request

3 and identify to the fullest extent practicable such re4 port or information;

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

6 information to the Secretary, shall state the reason

7 or purpose for the submission of such report or in8 formation and identify to the fullest extent prac9 ticable such report or information; and

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

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

12 information required under this subsection unless re13 quired for the medical welfare of an individual, to

14 determine risks to public health of a tobacco prod15 uct, or to verify a record, report, or information sub16 mitted under this chapter.

17 In prescribing regulations under this subsection, the Sec18 retary shall have due regard for the professional ethics of

19 the medical profession and the interests of patients. The

20 prohibitions of paragraph (6) continue to apply to records,

21 reports, and information concerning any individual who

22 has been a patient, irrespective of whether or when he

23 ceases to be a patient.

24 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.—
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1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), the Secretary shall by regulation require

3 a tobacco product manufacturer or importer of a to4 bacco product to report promptly to the Secretary

5 any corrective action taken or removal from the

6 market of a tobacco product undertaken by such

7 manufacturer or importer if the removal or correc8 tion was undertaken—

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

10 the tobacco product; or

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

12 caused by the tobacco product which may

13 present a risk to health.

14 A tobacco product manufacturer or importer of a to15 bacco product who undertakes a corrective action or

16 removal from the market of a tobacco product which

17 is not required to be reported under this subsection

18 shall keep a record of such correction or removal.

19 ‘‘(2) EXCEPTION.—No report of the corrective

20 action or removal of a tobacco product may be re21 quired under paragraph (1) if a report of the correc22 tive action or removal is required and has been sub23 mitted under subsection (a).
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1 ‘‘SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO

2 PRODUCTS.

3 ‘‘(a) IN GENERAL.—

4 ‘‘(1) PREMARKET APPROVAL REQUIRED.—

5 ‘‘(A) NEW PRODUCTS.—Approval under

6 this section of an application for premarket ap7 proval for any tobacco product that is not com8 mercially marketed (other than for test mar9 keting) in the United States as of August 11,

10 1995, is required unless the manufacturer has

11 submitted a report under section 905(j), and

12 the Secretary has issued an order that the to13 bacco product is substantially equivalent to a

14 tobacco product commercially marketed (other

15 than for test marketing) in the United States

16 as of August 11, 1995, that is in compliance

17 with the requirements of this Act.

18 ‘‘(B) PRODUCTS INTRODUCED BETWEEN

19 AUGUST 11, 1995, AND ENACTMENT OF THIS

20 CHAPTER.—Subparagraph (A) does not apply

21 to a tobacco product that—

22 ‘‘(i) was first introduced or delivered

23 for introduction into interstate commerce

24 for commercial distribution in the United

25 States after August 11, 1995, and before

26 the date of enactment of the Youth Smok-
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1 ing Prevention and Public Health Protec2 tion Act; and

3 ‘‘(ii) for which a report was submitted

4 under section 905(j) within 6 months after

5 such date,

6 until the Secretary issues an order that the to7 bacco product is substantially equivalent for

8 purposes of this section or requires premarket

9 approval.

10 ‘‘(2) SUBSTANTIALLY EQUIVALENT DEFINED.—

11 ‘‘(A) IN GENERAL.—For purposes of this

12 section and section 905(j), the terms ‘substan13 tially equivalent’ or ‘substantial equivalence’

14 mean, with respect to the tobacco product being

15 compared to the predicate tobacco product, that

16 the Secretary by order has found that the to17 bacco product—

18 ‘‘(i) has the same characteristics as

19 the predicate tobacco product; or

20 ‘‘(ii) has different characteristics and

21 the information submitted contains infor22 mation, including clinical data if deemed

23 necessary by the Secretary, that dem24 onstrates that it is not appropriate to reg25 ulate the product under this section be-
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1 cause the product does not raise different

2 questions of public health.

3 ‘‘(B) CHARACTERISTICS.—For purposes of

4 subparagraph (A), the term ‘characteristics’

5 means the materials, ingredients, design, com6 position, heating source, or other features of a

7 tobacco product.

8 ‘‘(C) LIMITATION.—A tobacco product may

9 not be found to be substantially equivalent to a

10 predicate tobacco product that has been re11 moved from the market at the initiative of the

12 Secretary or that has been determined by a ju13 dicial order to be misbranded or adulterated.

14 ‘‘(3) HEALTH INFORMATION.—

15 ‘‘(A) SUMMARY.—As part of a submission

16 under section 905(j) respecting a tobacco prod17 uct, the person required to file a premarket no18 tification under such section shall provide an

19 adequate summary of any health information

20 related to the tobacco product or state that

21 such information will be made available upon

22 request by any person.

23 ‘‘(B) REQUIRED INFORMATION.—Any sum24 mary under subparagraph (A) respecting a to25 bacco product shall contain detailed information
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1 regarding data concerning adverse health ef2 fects and shall be made available to the public

3 by the Secretary within 30 days of the issuance

4 of a determination that such tobacco product is

5 substantially equivalent to another tobacco

6 product.

7 ‘‘(b) APPLICATION.—

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

9 approval shall contain—

10 ‘‘(A) full reports of all information, pub11 lished or known to, or which should reasonably

12 be known to, the applicant, concerning inves13 tigations which have been made to show the

14 health risks of such tobacco product and wheth15 er such tobacco product presents less risk than

16 other tobacco products;

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

18 ingredients, and properties, and of the principle

19 or principles of operation, of such tobacco prod20 uct;

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

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

23 manufacture, processing, and, when relevant,

24 packing and installation of, such tobacco prod25 uct;
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1 ‘‘(D) an identifying reference to any per2 formance standard under section 907 which

3 would be applicable to any aspect of such to4 bacco product, and either adequate information

5 to show that such aspect of such tobacco prod6 uct fully meets such performance standard or

7 adequate information to justify any deviation

8 from such standard;

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

10 and of components thereof as the Secretary

11 may reasonably require;

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

13 be used for such tobacco product; and

14 ‘‘(G) such other information relevant to

15 the subject matter of the application as the Sec16 retary may require.

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

18 Upon receipt of an application meeting the require19 ments set forth in paragraph (1), the Secretary—

20 ‘‘(A) may, on the Secretary’s own initia21 tive; or

22 ‘‘(B) shall, upon the request of an appli23 cant,

24 refer such application to an advisory committee and

25 for submission (within such period as the Secretary
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1 may establish) of a report and recommendation re2 specting approval of the application, together with

3 all underlying data and the reasons or basis for the

4 recommendation.

5 ‘‘(c) ACTION ON APPLICATION.—

6 ‘‘(1) DEADLINE.—

7 ‘‘(A) IN GENERAL.—As promptly as pos8 sible, but in no event later than 180 days after

9 the receipt of an application under subsection

10 (b), the Secretary, after considering the report

11 and recommendation submitted under para12 graph (2) of such subsection, shall—

13 ‘‘(i) issue an order approving the ap14 plication if the Secretary finds that none of

15 the grounds for denying approval specified

16 in paragraph (2) of this subsection applies;

17 or

18 ‘‘(ii) deny approval of the application

19 if the Secretary finds (and sets forth the

20 basis for such finding as part of or accom21 panying such denial) that one or more

22 grounds for denial specified in paragraph

23 (2) of this subsection apply.

24 ‘‘(B) RESTRICTIONS ON SALE AND DIS25 TRIBUTION.—An order approving an application
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1 for a tobacco product may require as a condi2 tion to such approval that the sale and distribu3 tion of the tobacco product be restricted but

4 only to the extent that the sale and distribution

5 of a tobacco product may be restricted under a

6 regulation under section 906(d).

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

8 shall deny approval of an application for a tobacco

9 product if, upon the basis of the information sub10 mitted to the Secretary as part of the application

11 and any other information before the Secretary with

12 respect to such tobacco product, the Secretary finds

13 that—

14 ‘‘(A) there is a lack of a showing that per15 mitting such tobacco product to be marketed

16 would be appropriate for the protection of the

17 public health;

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

19 or controls used for, the manufacture, proc20 essing, or packing of such tobacco product do

21 not conform to the requirements of section

22 906(e);

23 ‘‘(C) based on a fair evaluation of all mate24 rial facts, the proposed labeling is false or mis25 leading in any particular; or
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1 ‘‘(D) such tobacco product is not shown to

2 conform in all respects to a performance stand3 ard in effect under section 907, compliance with

4 which is a condition to approval of the applica5 tion, and there is a lack of adequate informa6 tion to justify the deviation from such standard.

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

8 application shall, insofar as the Secretary determines

9 to be practicable, be accompanied by a statement in10 forming the applicant of the measures required to

11 place such application in approvable form (which

12 measures may include further research by the appli13 cant in accordance with one or more protocols pre14 scribed by the Secretary).

15 ‘‘(4) BASIS FOR FINDING.—For purposes of

16 this section, the finding as to whether approval of a

17 tobacco product is appropriate for the protection of

18 the public health shall be determined with respect to

19 the risks and benefits to the population as a whole,

20 including users and non-users of the tobacco prod21 uct, and taking into account—

22 ‘‘(A) the increased or decreased likelihood

23 that existing users of tobacco products will stop

24 using such products; and
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1 ‘‘(B) the increased or decreased likelihood

2 that those who do not use tobacco products will

3 start using such products.

4 ‘‘(5) BASIS FOR ACTION.—

5 ‘‘(A) INVESTIGATIONS.—For purposes of

6 paragraph (2)(A), whether permitting a tobacco

7 product to be marketed would be appropriate

8 for the protection of the public health shall,

9 when appropriate, be determined on the basis of

10 well-controlled investigations, which may in11 clude one or more clinical investigations by ex12 perts qualified by training and experience to

13 evaluate the tobacco product.

14 ‘‘(B) OTHER EVIDENCE.—If the Secretary

15 determines that there exists valid scientific evi16 dence (other than evidence derived from inves17 tigations described in subparagraph (A)) which

18 is sufficient to evaluate the tobacco product the

19 Secretary may authorize that the determination

20 for purposes of paragraph (2)(A) be made on

21 the basis of such evidence.

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

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

24 obtaining, where appropriate, advice on scientific

25 matters from an advisory committee, and after due
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1 notice and opportunity for informal hearing to the

2 holder of an approved application for a tobacco

3 product, issue an order withdrawing approval of the

4 application if the Secretary finds—

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

6 tobacco product no longer is appropriate for the

7 protection of the public health;

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

9 accompanied by an untrue statement of a mate10 rial fact;

11 ‘‘(C) that the applicant—

12 ‘‘(i) has failed to establish a system

13 for maintaining records, or has repeatedly

14 or deliberately failed to maintain records

15 or to make reports, required by an applica16 ble regulation under section 909;

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

18 or copying or verification of, such records

19 as required by section 704; or

20 ‘‘(iii) has not complied with the re21 quirements of section 905;

22 ‘‘(D) on the basis of new information be23 fore the Secretary with respect to such tobacco

24 product, evaluated together with the evidence

25 before the Secretary when the application was
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1 approved, that the methods used in, or the fa2 cilities and controls used for, the manufacture,

3 processing, packing, or installation of such to4 bacco product do not conform with the require5 ments of section 906(e) and were not brought

6 into conformity with such requirements within

7 a reasonable time after receipt of written notice

8 from the Secretary of nonconformity;

9 ‘‘(E) on the basis of new information be10 fore the Secretary, evaluated together with the

11 evidence before the Secretary when the applica12 tion was approved, that the labeling of such to13 bacco product, based on a fair evaluation of all

14 material facts, is false or misleading in any par15 ticular and was not corrected within a reason16 able time after receipt of written notice from

17 the Secretary of such fact; or

18 ‘‘(F) on the basis of new information be19 fore the Secretary, evaluated together with the

20 evidence before the Secretary when the applica21 tion was approved, that such tobacco product is

22 not shown to conform in all respects to a per23 formance standard which is in effect under sec24 tion 907, compliance with which was a condi25 tion to approval of the application, and that
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1 there is a lack of adequate information to jus2 tify the deviation from such standard.

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

4 subject to an order issued under paragraph (1) with5 drawing approval of the application may, by petition

6 filed on or before the 30th day after the date upon

7 which such holder receives notice of such with8 drawal, obtain review thereof in accordance with

9 subsection (e).

10 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro11 viding an opportunity for an informal hearing, the

12 Secretary determines there is reasonable probability

13 that the continuation of distribution of a tobacco

14 product under an approved application would cause

15 serious, adverse health consequences or death, that

16 is greater than ordinarily caused by tobacco prod17 ucts on the market, the Secretary shall by order

18 temporarily suspend the approval of the application

19 approved under this section. If the Secretary issues

20 such an order, the Secretary shall proceed expedi21 tiously under paragraph (1) to withdraw such appli22 cation.

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

24 Secretary under this section shall be served—
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1 ‘‘(1) in person by any officer or employee of the

2 department designated by the Secretary; or

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

4 certified mail addressed to the applicant at the ap5 plicant’s last known address in the records of the

6 Secretary.

7 ‘‘SEC. 911. JUDICIAL REVIEW.

8 ‘‘(a) RIGHT TO REVIEW.—

9 ‘‘(1) IN GENERAL.—Not later than 30 days

10 after—

11 ‘‘(A) the promulgation of a regulation

12 under section 907 establishing, amending, or

13 revoking a performance standard for a tobacco

14 product; or

15 ‘‘(B) a denial of an application for ap16 proval under section 910(c),

17 any person adversely affected by such regulation or

18 order may file a petition with the United States

19 Court of Appeals for the District of Columbia or for

20 the circuit wherein such person resides or has his or

21 her principal place of business for judicial review of

22 such regulation or order.

23 ‘‘(2) REQUIREMENTS.—

24 ‘‘(A) COPY OF PETITION.—A copy of the

25 petition filed under paragraph (1) shall be
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1 transmitted by the clerk of the court to the Sec2 retary or other officer designated by the Sec3 retary for that purpose.

4 ‘‘(B) RECORD OF PROCEEDINGS.—With re5 spect to an action under paragraph (1), the

6 Secretary shall file in the court the record of

7 the proceedings on which the Secretary based

8 the Secretary’s regulation or order and each

9 record or order shall contain a statement of the

10 reasons for its issuance and the basis, on the

11 record, for its issuance.

12 ‘‘(C) DEFINITION.—For purposes of this

13 section, the term ‘record’ means all notices and

14 other matter published in the Federal Register

15 with respect to the regulation or order reviewed,

16 all information submitted to the Secretary with

17 respect to such regulation or order, proceedings

18 of any panel or advisory committee with respect

19 to such regulation or order, any hearing held

20 with respect to such regulation or order, and

21 any other information identified by the Sec22 retary, in the administrative proceeding held

23 with respect to such regulation or order, as

24 being relevant to such regulation or order.
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1 ‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD2 DITIONAL FINDINGS.—

3 ‘‘(1) IN GENERAL.—If the petitioner in an ac4 tion under subsection (a)(1) applies to the court for

5 leave to adduce additional data, views, or arguments

6 respecting the regulation or order being reviewed

7 and shows to the satisfaction of the court that such

8 additional data, views, or arguments are material

9 and that there were reasonable grounds for the peti10 tioner’s failure to adduce such data, views, or argu11 ments in the proceedings before the Secretary, the

12 court may order the Secretary to provide additional

13 opportunity for the oral presentation of data, views,

14 or arguments and for written submissions.

15 ‘‘(2) MODIFICATION OF OR ADDITIONAL FIND16 INGS.—The Secretary may modify the Secretary’s

17 findings, or make new findings by reason of the ad18 ditional data, views, or arguments under paragraph

19 (1) and shall file with the court such modified or

20 new findings, and the Secretary’s recommendation,

21 if any, for the modification or setting aside of the

22 regulation or order being reviewed, with the return

23 of such additional data, views, or arguments.

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

25 petition under subsection (a) for judicial review of a regu-
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1 lation or order, the court shall have jurisdiction to review

2 the regulation or order in accordance with chapter 7 of

3 title 5, United States Code, and to grant appropriate re4 lief, including interim relief, as provided in such chapter.

5 A regulation or order described in paragraph (1) or (2)

6 of subsection (a) shall not be affirmed if it is found to

7 be unsupported by substantial evidence on the record

8 taken as a whole.

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

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

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

12 Supreme Court of the United States upon certiorari or

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

14 United States Code.

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

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

17 any other remedies provided by law.

18 ‘‘(f) REGULATIONS AND ORDERS MUST RECITE

19 BASIS IN RECORD.—To facilitate judicial review under

20 this section or under any other provision of law or a regu21 lation or order issued under section 906, 907, 908, 909,

22 910, or 914, each such regulation or order shall contain

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

24 in the record of the proceedings held in connection with

25 its issuance, for its issuance.
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1 ‘‘SEC. 912. POSTMARKET SURVEILLANCE.

2 ‘‘(a) DISCRETIONARY SURVEILLANCE.—The Sec3 retary may require a tobacco product manufacturer to

4 conduct postmarket surveillance for a tobacco product of

5 the manufacturer if the Secretary determines that

6 postmarket surveillance of the tobacco product is nec7 essary to protect the public health or is necessary to pro8 vide information regarding the health risks and other safe9 ty issues involving the tobacco product.

10 ‘‘(b) SURVEILLANCE APPROVAL.—Each tobacco

11 product manufacturer required to conduct a surveillance

12 of a tobacco product under subsection (a) shall, within 30

13 days after receiving notice that the manufacturer is re14 quired to conduct such surveillance, submit, for the ap15 proval of the Secretary, a protocol for the required surveil16 lance. The Secretary, within 60 days of the receipt of such

17 protocol, shall determine if the principal investigator pro18 posed to be used in the surveillance has sufficient quali19 fications and experience to conduct such surveillance and

20 if such protocol will result in collection of useful data or

21 other information necessary to protect the public health.

22 The Secretary may not approve such a protocol until it

23 has been reviewed by an appropriately qualified scientific

24 and technical review committee established by the Sec25 retary.
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1 ‘‘SEC. 913. REDUCED RISK TOBACCO PRODUCTS.

2 ‘‘(a) REQUIREMENTS.—

3 ‘‘(1) IN GENERAL.—For purposes of this sec4 tion, the term ‘reduced risk tobacco product’ means

5 a tobacco product designated by the Secretary under

6 paragraph (2).

7 ‘‘(2) DESIGNATION.—

8 ‘‘(A) IN GENERAL.—A product may be

9 designated by the Secretary as a reduced risk

10 tobacco product if the Secretary finds that the

11 product will significantly reduce harm to indi12 viduals caused by a tobacco product and is oth13 erwise appropriate to protect public health,

14 based on an application submitted by the manu15 facturer of the product (or other responsible

16 person) that—

17 ‘‘(i) demonstrates through testing on

18 animals and short-term human testing that

19 use of such product results in ingestion or

20 inhalation of a substantially lower yield of

21 toxic substances than use of conventional

22 tobacco products in the same category as

23 the proposed reduced risk product; and

24 ‘‘(ii) if required by the Secretary, in25 cludes studies of the long-term health ef26 fects of the product.
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1 If such studies are required, the manufacturer

2 may consult with the Secretary regarding proto3 cols for conducting the studies.

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

5 finding under subparagraph (A), the Secretary

6 shall take into account—

7 ‘‘(i) the risks and benefits to the pop8 ulation as a whole, including both users of

9 tobacco products and non-users of tobacco

10 products;

11 ‘‘(ii) the increased or decreased likeli12 hood that existing users of tobacco prod13 ucts will stop using such products includ14 ing reduced risk tobacco products;

15 ‘‘(iii) the increased or decreased likeli16 hood that those who do not use tobacco

17 products will start to use such products,

18 including reduced risk tobacco products;

19 and

20 ‘‘(iv) the risks and benefits to con21 sumers from the use of a reduced risk to22 bacco product as compared to the use of

23 products approved under chapter V to re24 duce exposure to tobacco.
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1 ‘‘(3) MARKETING REQUIREMENTS.—A tobacco

2 product may be marketed and labeled as a reduced

3 risk tobacco product if it—

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

5 tobacco product by the Secretary under para6 graph (2);

7 ‘‘(B) bears a label prescribed by the Sec8 retary concerning the product’s contribution to

9 reducing harm to health; and

10 ‘‘(C) complies with requirements prescribed

11 by the Secretary relating to marketing and ad12 vertising of the product, and other provisions of

13 this chapter as prescribed by the Secretary.

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

15 after the date on which a tobacco product is designated

16 as a reduced risk tobacco product under this section the

17 Secretary may, after providing an opportunity for an in18 formal hearing, revoke such designation if the Secretary

19 determines, based on information not available at the time

20 of the designation, that—

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

22 is no longer valid; or

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

24 of subsection (a)(3).
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1 ‘‘(c) LIMITATION.—A tobacco product that is des2 ignated as a reduced risk tobacco product that is in com3 pliance with subsection (a) shall not be regulated as a

4 drug or device.

5 ‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO

6 PRODUCT TECHNOLOGY.—A tobacco product manufac7 turer shall provide written notice to the Secretary upon

8 the development or acquisition by the manufacturer of any

9 technology that would reduce the risk of a tobacco product

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

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

12 under subsection (a).

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

14 ‘‘The Secretary shall issue regulations to require that

15 retail establishments for which the predominant business

16 is the sale of tobacco products comply with any advertising

17 restrictions applicable to retail establishments accessible

18 to individuals under the age of 18.

19 ‘‘SEC. 915. JURISDICTION OF AND COORDINATION WITH

20 THE FEDERAL TRADE COMMISSION.

21 ‘‘(a) JURISDICTION.—

22 ‘‘(1) IN GENERAL.—Except where expressly

23 provided in this chapter, nothing in this chapter

24 shall be construed as limiting or diminishing the au25 thority of the Federal Trade Commission to enforce
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1 the laws under its jurisdiction with respect to the

2 advertising, sale, or distribution of tobacco products.

3 ‘‘(2) ENFORCEMENT.—Any advertising that vio4 lates this chapter or part 897 of title 21, Code of

5 Federal Regulations, is an unfair or deceptive act or

6 practice under section 5(a) of the Federal Trade

7 Commission Act (15 U.S.C. 45(a)) and shall be con8 sidered a violation of a rule promulgated under sec9 tion 18 of that Act (15 U.S.C. 57a).

10 ‘‘(b) COORDINATION.—With respect to the require11 ments of section 4 of the Federal Cigarette Labeling and

12 Advertising Act (15 U.S.C. 1333) and section 3 of the

13 Comprehensive Smokeless Tobacco Health Education Act

14 of 1986 (15 U.S.C. 4402)—

15 ‘‘(1) the Chairman of the Federal Trade Com16 mission shall coordinate with the Secretary con17 cerning the enforcement of such Act as such enforce18 ment relates to unfair or deceptive acts or practices

19 in the advertising of cigarettes or smokeless tobacco;

20 and

21 ‘‘(2) the Secretary shall consult with the Chair22 man of such Commission in revising the label state23 ments and requirements under such sections.
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1 ‘‘SEC. 916. CONGRESSIONAL REVIEW PROVISIONS.

2 ‘‘In accordance with section 801 of title 5, United

3 States Code, the Congress shall review, and may dis4 approve, any rule under this chapter that is subject to sec5 tion 801. This section does not apply to the rule set forth

6 in part 897 of title 21, Code of Federal Regulations.

7 ‘‘SEC. 917. REGULATION REQUIREMENT.

8 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not

9 later than 24 months after the date of enactment of the

10 Youth Smoking Prevention and Public Health Protection

11 Act, the Secretary, acting through the Commissioner of

12 the Food and Drug Administration, shall promulgate reg13 ulations under this Act that meet the requirements of sub14 section (b).

15 ‘‘(b) CONTENTS OF RULES.—The regulations pro16 mulgated under subsection (a) shall require the testing,

17 reporting, and disclosure of tobacco product smoke con18 stituents and ingredients that the Secretary determines

19 should be disclosed to the public in order to protect the

20 public health. Such constituents shall include tar, nicotine,

21 carbon monoxide, and such other smoke constituents or

22 ingredients as the Secretary may determine to be appro23 priate. The regulations may require that tobacco product

24 manufacturers, packagers, or importers make such disclo25 sures relating to tar and nicotine through labels or adver26 tising, and make such disclosures regarding other smoke
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1 constituents or ingredients as the Secretary determines

2 are necessary to protect the public health.

3 ‘‘(c) AUTHORITY.—The Food and Drug Administra4 tion shall have the authority under this chapter to conduct

5 or to require the testing, reporting, or disclosure of to6 bacco product smoke constituents.

7 ‘‘SEC. 918. PRESERVATION OF STATE AND LOCAL AUTHOR8 ITY.

9 ‘‘(a) ADDITIONAL REQUIREMENTS.—

10 ‘‘(1) IN GENERAL.—Except as provided in para11 graph (2), nothing in this chapter, or rules promul12 gated under this chapter, shall be construed to limit

13 the authority of a Federal agency (including the

14 Armed Forces), a State or political subdivision of a

15 State, or the government of an Indian tribe to enact,

16 adopt, promulgate, and enforce any law, rule, regu17 lation, or other measure with respect to tobacco

18 products, including laws, rules, regulations, or other

19 measures relating to or prohibiting the sale, dis20 tribution, possession, exposure to, or use of tobacco

21 products by individuals of any age that are in addi22 tion to, or more stringent than, requirements estab23 lished under this chapter. No provision of this chap24 ter shall limit or otherwise affect any State, Tribal,

25 or local taxation of tobacco products.
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1 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

2 LOCAL REQUIREMENTS.—

3 ‘‘(A) IN GENERAL.—Except as provided in

4 subparagraph (B), no State or political subdivi5 sion of a State may establish or continue in ef6 fect with respect to a tobacco product any re7 quirement which is different from, or in addi8 tion to, any requirement applicable under the

9 provisions of this chapter relating to perform10 ance standards, premarket approval, adultera11 tion, misbranding, registration, reporting, good

12 manufacturing standards, or reduced risk prod13 ucts.

14 ‘‘(B) EXCEPTION.—Subparagraph (A)

15 does not apply to requirements relating to the

16 sale, use, or distribution of a tobacco product

17 including requirements related to the access to,

18 and the advertising and promotion of, a tobacco

19 product.

20 ‘‘(b) ADDITIONAL RESTRICTIONS ON UNDERAGE

21 USAGE.—Nothing in this chapter shall be construed to

22 prevent a Federal agency (including the Armed Forces),

23 a State or a political subdivision of a State, or the govern24 ment of an Indian tribe from adopting and enforcing addi25 tional measures that further restrict or prohibit tobacco
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1 product sale to, use by, and accessibility to individuals

2 under the legal age of purchase established by such agen3 cy, State, subdivision, or government of an Indian tribe.

4 ‘‘(c) NO LESS STRINGENT.—Nothing in this chapter

5 is intended to supersede any State, local, or Tribal law

6 that is not less stringent than this chapter.

7 ‘‘(d) RULE OF CONSTRUCTION REGARDING PRODUCT

8 LIABILITY.—No provision of this chapter relating to a to9 bacco product shall be construed to modify or otherwise

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

11 product liability law of any State.

12 ‘‘(e) WAIVERS.—Upon the application of a State or

13 political subdivision thereof, the Secretary may, by regula14 tion promulgated after notice and an opportunity for an

15 oral hearing, exempt from subsection (a), under such con16 ditions as may be prescribed in such regulation, a require17 ment of such State or political subdivision applicable to

18 a tobacco product if—

19 ‘‘(1) the requirement is more stringent than a

20 requirement applicable under the provisions de21 scribed in subsection (a)(1) which would be applica22 ble to the tobacco product if an exemption were not

23 in effect under this subsection; or

24 ‘‘(2) the requirement—
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1 ‘‘(A) is required by compelling local condi2 tions; and

3 ‘‘(B) compliance with the requirement

4 would not cause the tobacco product to be in

5 violation of any applicable requirement of this

6 chapter.’’.

7 SEC. 102. CONSTRUCTION OF CURRENT REGULATIONS.

8 (a) IN GENERAL.—The final regulations promulgated

9 by the Secretary of Health and Human Services in the

10 August 28, 1996, issue of the Federal Register (62 Fed.

11 Reg. 44615–44618) and codified at part 897 of title 21,

12 Code of Federal Regulations, are hereby deemed to be law13 ful and to have been lawfully promulgated by the Sec14 retary under chapter IX and section 701 of the Federal

15 Food, Drug, and Cosmetic Act, as amended by this Act,

16 and not under chapter V of the Federal Food, Drug, and

17 Cosmetic Act. The provisions of such part 897 shall take

18 effect on the date of enactment of this Act or upon such

19 later date as determined by the Secretary by order. The

20 Secretary shall amend the designation of authority in such

21 regulations in accordance with this subsection.

22 (b) LIMITATION ON ADVISORY OPINIONS.—As of the

23 date of enactment of this Act, the following documents

24 issued by the Food and Drug Administration shall not

25 constitute advisory opinions under section 10.85(d)(1) of
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1 title 21, Code of Federal Regulations, except as they apply

2 to tobacco products, and shall not be cited by the Sec3 retary of Health and Human Services or the Food and

4 Drug Administration as binding precedent:

5 (1) The preamble to the proposed rule in the

6 document entitled ‘‘Regulations Restricting the Sale

7 and Distribution of Cigarettes and Smokeless To8 bacco Products to Protect Children and Adoles9 cents’’ (60 Fed. Reg. 41314–41372 (August 11,

10 1995)).

11 (2) The document entitled ‘‘Nicotine in Ciga12 rettes and Smokeless Tobacco Products is a Drug

13 and These Products Are Nicotine Delivery Devices

14 Under the Federal Food, Drug, and Cosmetic Act’’

15 (60 Fed. Reg. 41453–41787 (August 11, 1995)).

16 (3) The preamble to the final rule in the docu17 ment entitled ‘‘Regulations Restricting the Sale and

18 Distribution of Cigarettes and Smokeless Tobacco to

19 Protect Children and Adolescents’’ (61 Fed. Reg.

20 44396–44615 (August 28, 1996)).

21 (4) The document entitled ‘‘Nicotine in Ciga22 rettes and Smokeless Tobacco is a Drug and These

23 Products are Nicotine Delivery Devices Under the

24 Federal Food, Drug, and Cosmetic Act; Jurisdic-
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1 tional Determination’’ (61 Fed. Reg. 44619–45318

2 (August 28, 1996)).

3 SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GEN4 ERAL PROVISIONS.

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

6 COSMETIC ACT.—Except as otherwise expressly provided,

7 whenever in this section an amendment is expressed in

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

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

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

11 301 et seq.).

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

13 amended—

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

15 product,’’ after ‘‘device,’’;

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

17 product,’’ after ‘‘device,’’;

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

19 product,’’ after ‘‘device,’’;

20 (4) in subsection (e), by striking ‘‘515(f), or

21 519’’ and inserting ‘‘515(f), 519, or 909’’;

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

23 product,’’ after ‘‘device,’’;

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

25 product,’’ after ‘‘device,’’;
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1 (7) in subsection (j), by striking ‘‘708, or 721’’

2 and inserting ‘‘708, 721, 904, 905, 906, 907, 908,

3 or 909’’;

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

5 product,’’ after ‘‘device,’’;

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

7 following:

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

9 510 or 905, the failure to provide any information re10 quired by section 510(j), 510(k), 905(i), or 905(j), or the

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

12 or 905(j)(2).’’;

13 (10) by striking subsection (q)(1) and inserting

14 the following:

15 ‘‘(q)(1) The failure or refusal—

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

17 under section 518, 520(g), 906(f), or 908;

18 ‘‘(B) to furnish any notification or other mate19 rial or information required by or under section 519,

20 520(g), 904, 906(f), or 909; or

21 ‘‘(C) to comply with a requirement under sec22 tion 522 or 912.’’;

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

24 and inserting ‘‘device or tobacco product,’’;
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1 (12) in subsection (r), by inserting ‘‘or tobacco

2 product’’ after ‘‘device’’ each time that it appears;

3 and

4 (13) by adding at the end the following:

5 ‘‘(aa) The sale of tobacco products in violation

6 of a no-tobacco-sale order issued under section

7 303(f).’’.

8 (c) SECTION 303.—Section 303(f) (21 U.S.C. 333(f))

9 is amended—

10 (1) by striking the subsection heading and in11 serting the following:

12 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR13 DERS.—’’;

14 (2) in paragraph (1)(A), by inserting ‘‘or to15 bacco products’’ after ‘‘devices’’;

16 (3) by redesignating paragraphs (3), (4), and

17 (5) as paragraphs (4), (5), and (6), and inserting

18 after paragraph (2) the following:

19 ‘‘(3) If the Secretary finds that a person has

20 committed repeated violations of restrictions promul21 gated under section 906(d) at a particular retail out22 let then the Secretary may impose a no-tobacco-sale

23 order on that person prohibiting the sale of tobacco

24 products in that outlet. A no-tobacco-sale order may
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1 be imposed with a civil penalty under paragraph

2 (1).’’;

3 (4) in paragraph (4) as so redesignated—

4 (A) in subparagraph (A)—

5 (i) by striking ‘‘assessed’’ the first

6 time it appears and inserting ‘‘assessed, or

7 a no-tobacco-sale order may be imposed,’’;

8 and

9 (ii) by striking ‘‘penalty’’ and insert10 ing ‘‘penalty, or upon whom a no-tobacco11 order is to be imposed,’’;

12 (B) in subparagraph (B)—

13 (i) by inserting after ‘‘penalty,’’ the

14 following: ‘‘or the period to be covered by

15 a no-tobacco-sale order,’’; and

16 (ii) by adding at the end the fol17 lowing: ‘‘A no-tobacco-sale order perma18 nently prohibiting an individual retail out19 let from selling tobacco products shall in20 clude provisions that allow the outlet, after

21 a specified period of time, to request that

22 the Secretary compromise, modify, or ter23 minate the order.’’; and

24 (C) by adding at the end, the following:
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1 ‘‘(D) The Secretary may compromise, mod2 ify, or terminate, with or without conditions,

3 any no-tobacco-sale order.’’;

4 (5) in paragraph (5) as so redesignated—

5 (A) by striking ‘‘(3)(A)’’ as resdesignated,

6 and inserting ‘‘(4)(A)’’;

7 (B) by inserting ‘‘or the imposition of a

8 no-tobacco-sale order’’ after ‘‘penalty’’ the first

9 2 places it appears; and

10 (C) by striking ‘‘issued.’’ and inserting

11 ‘‘issued, or on which the no-tobacco-sale order

12 was imposed, as the case may be.’’; and

13 (6) in paragraph (6), as so redesignated, by

14 striking ‘‘paragraph (4)’’ each place it appears and

15 inserting ‘‘paragraph (5)’’.

16 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is

17 amended—

18 (1) in subsection (a)(2)—

19 (A) by striking ‘‘and’’ before ‘‘(D)’’; and

20 (B) by striking ‘‘device.’’ and inserting the

21 following: ‘‘, (E) Any adulterated or misbranded

22 tobacco product.’’;

23 (2) in subsection (d)(1), by inserting ‘‘tobacco

24 product,’’ after ‘‘device,’’;
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1 (3) in subsection (g)(1), by inserting ‘‘or to2 bacco product’’ after ‘‘device’’ each place it appears;

3 and

4 (4) in subsection (g)(2)(A), by inserting ‘‘or to5 bacco product’’ after ‘‘device’’ each place it appears.

6 (e) SECTION 702.—Section 702(a) (21 U.S.C.

7 372(a)) is amended—

8 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and

9 (2) by adding at the end thereof the following:

10 ‘‘(2) For a tobacco product, to the extent feasible,

11 the Secretary shall contract with the States in accordance

12 with paragraph (1) to carry out inspections of retailers

13 in connection with the enforcement of this Act.’’.

14 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is

15 amended—

16 (1) by inserting ‘‘tobacco product,’’ after ‘‘de17 vice,’’ each place it appears; and

18 (2) by inserting ‘‘tobacco products,’’ after ‘‘de19 vices,’’ each place it appears.

20 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is

21 amended—

22 (1) in subsection (a)(1)(A), by inserting ‘‘to23 bacco products,’’ after ‘‘devices,’’ each place it ap24 pears;
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1 (2) in subsection (a)(1)(B), by inserting ‘‘or to2 bacco product’’ after ‘‘restricted devices’’ each place

3 it appears; and

4 (3) in subsection (b), by inserting ‘‘tobacco

5 product,’’ after ‘‘device,’’.

6 (h) SECTION 705.—Section 705(b) (21 U.S.C.

7 375(b)) is amended by inserting ‘‘tobacco products,’’ after

8 ‘‘devices,’’.

9 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is

10 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’.

11 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is

12 amended—

13 (1) in subsection (a)—

14 (A) by inserting ‘‘tobacco products,’’ after

15 ‘‘devices,’’ the first time it appears;

16 (B) by inserting ‘‘or subsection (j) of sec17 tion 905’’ after ‘‘section 510’’; and

18 (C) by striking ‘‘drugs or devices’’ each

19 time it appears and inserting ‘‘drugs, devices,

20 or tobacco products’’;

21 (2) in subsection (e)—

22 (A) in paragraph (1), by inserting ‘‘tobacco

23 product,’’ after ‘‘device,’’; and
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1 (B) by redesignating paragraph (4) as

2 paragraph (5) and inserting after paragraph

3 (3), the following:

4 ‘‘(4) Paragraph (1) does not apply to any to5 bacco product—

6 ‘‘(A) which does not comply with an appli7 cable requirement of section 907 or 910; or

8 ‘‘(B) which under section 906(f) is exempt

9 from either such section.

10 This paragraph does not apply if the Secretary has

11 determined that the exportation of the tobacco prod12 uct is not contrary to the public health and safety

13 and has the approval of the country to which it is

14 intended for export or the tobacco product is eligible

15 for export under section 802.’’.

16 (k) SECTION 802.—Section 802 (21 U.S.C. 382) is

17 amended—

18 (1) in subsection (a), by striking ‘‘device—’’

19 and inserting ‘‘device or tobacco product—’’;

20 (2) in subsection (a)(1)(C), by striking ‘‘and’’

21 after the semicolon;

22 (3) in subsection (a)(2), by striking subpara23 graph (C) and all that follows in that subsection and

24 inserting the following:
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1 ‘‘(C) is a banned device under section 516;

2 or

3 ‘‘(3) which, in the case of a tobacco product—

4 ‘‘(A) does not comply with an applicable

5 requirement of section 907 or 910; or

6 ‘‘(B) under section 906(f) is exempt from

7 either such section,

8 is adulterated, misbranded, and in violation of such

9 sections or Act unless the export of the drug, device,

10 or tobacco product is, except as provided in sub11 section (f), authorized under subsection (b), (c), (d),

12 or (e) of this section or section 801(e)(2) or

13 801(e)(4). If a drug, device, or tobacco product de14 scribed in paragraph (1), (2), or (3) may be ex15 ported under subsection (b) and if an application for

16 such drug or device under section 505, 515, or 910

17 of this Act or section 351 of the Public Health Serv18 ice Act (42 U.S.C. 262) was disapproved, the Sec19 retary shall notify the appropriate public health offi20 cial of the country to which such drug, device, or to21 bacco product will be exported of such disapproval.’’;

22 (4) in subsection (b)(1)(A), by inserting ‘‘or to23 bacco product’’ after ‘‘device’’ each time it appears;
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1 (5) in subsection (c), by inserting ‘‘or tobacco

2 product’’ after ‘‘device’’ and inserting ‘‘or section

3 906(f)’’ after ‘‘520(g).’’;

4 (6) in subsection (f), by inserting ‘‘or tobacco

5 product’’ after ‘‘device’’ each time it appears; and

6 (7) in subsection (g), by inserting ‘‘or tobacco

7 product’’ after ‘‘device’’ each time it appears.

8 (l) SECTION 1003.—Section 1003(d)(2)(C) (as redes9 ignated by section 101(a)) is amended—

10 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and

11 (2) inserting a comma and ‘‘and tobacco prod12 ucts’’ after ‘‘devices’’.

13 (m) EFFECTIVE DATE FOR NO-TOBACCO-SALE

14 ORDER AMENDMENTS.—The amendments made by sub15 section (c), other than the amendment made by paragraph

16 (2) of such subsection, shall take effect only upon the pro17 mulgation of final regulations by the Secretary of Health

18 and Human Services—

19 (1) defining the term ‘‘repeated violation’’, as

20 used in section 303(f) of the Federal Food, Drug,

21 and Cosmetic Act (21 U.S.C. 333(f)) as amended by

22 subsection (c), by identifying the number of viola23 tions of particular requirements over a specified pe24 riod of time that constitute a repeated violation;
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1 (2) providing for notice to the retailer of each

2 violation at a particular retail outlet;

3 (3) providing that a person may not be charged

4 with a violation at a particular retail outlet unless

5 the Secretary has provided notice to the retailer of

6 all previous violations at that outlet;

7 (4) establishing a period of time during which,

8 if there are no violations by a particular retail out9 let, that outlet will not considered to have been the

10 site of repeated violations when the next violation oc11 curs; and

12 (5) providing that good faith reliance on false

13 identification does not constitute a violation of any

14 minimum age requirement for the sale of tobacco

15 products.

16 TITLE II—TOBACCO PRODUCT

17 WARNINGS AND SMOKE CON18 STITUENT DISCLOSURE

19 SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

20 (a) IN GENERAL.—Section 4 of the Federal Cigarette

21 Labeling and Advertising Act (15 U.S.C. 1333) is amend22 ed to read as follows:

23 ‘‘SEC. 4. LABELING.

24 ‘‘(a) LABEL REQUIREMENTS.—
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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 ciga4 rettes the package of which fails to bear, in accord5 ance with the requirements of this section, one of

6 the following labels:

7 ‘‘WARNING: Cigarettes are addictive’’

8 ‘‘WARNING: Tobacco smoke can harm your chil9 dren’’

10 ‘‘WARNING: Cigarettes cause fatal lung disease’’

11 ‘‘WARNING: Cigarettes cause cancer’’

12 ‘‘WARNING: Cigarettes cause strokes and heart

13 disease’’

14 ‘‘WARNING: Smoking during pregnancy can harm

15 your baby’’

16 ‘‘WARNING: Smoking can kill you’’

17 ‘‘WARNING: Tobacco smoke causes fatal lung dis18 ease in non-smokers’’

19 ‘‘WARNING: Quitting smoking now greatly reduces

20 serious risks to your health’’

21 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

22 ‘‘(A) IN GENERAL.—Each label statement

23 required by paragraph (1) shall be located in

24 the upper portion of the front and rear panels

25 of the package, directly on the package under-
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1 neath the cellophane or other clear wrapping.

2 Except as provided in subparagraph (B), each

3 label statement shall comprise at least the top

4 25 percent of the front and rear panels of the

5 package. The word ‘‘WARNING’’ shall appear

6 in capital letters and all text shall be in con7 spicuous and legible 17-point type, unless the

8 text of the label statement would occupy more

9 than 70 percent of such area, in which case the

10 text may be in a smaller conspicuous and leg11 ible type size, provided that at least 60 percent

12 of such area is occupied by required text. The

13 text shall be black on a white background, or

14 white on a black background, in a manner that

15 contrasts, by typography, layout, or color, with

16 all other printed material on the package, in an

17 alternating fashion under the plan submitted

18 under subsection (b)(4).

19 ‘‘(B) FLIP-TOP BOXES.—For any cigarette

20 brand package manufactured or distributed be21 fore January 1, 2000, which employs a flip-top

22 style (if such packaging was used for that

23 brand in commerce prior to June 21, 1997), the

24 label statement required by paragraph (1) shall

25 be located on the flip-top area of the package,
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1 even if such area is less than 25 percent of the

2 area of the front panel. Except as provided in

3 this paragraph, the provisions of this subsection

4 shall apply to such packages.

5 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU6 TION.—The provisions of this subsection do not

7 apply to a tobacco product manufacturer or dis8 tributor of cigarettes which does not manufacture,

9 package, or import cigarettes for sale or distribution

10 within the United States.

11 ‘‘(b) ADVERTISING REQUIREMENTS.—

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

13 tobacco product manufacturer, importer, distributor,

14 or retailer of cigarettes to advertise or cause to be

15 advertised within the United States any cigarette

16 unless its advertising bears, in accordance with the

17 requirements of this section, one of the labels speci18 fied in subsection (a) of this section.

19 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement

20 required by subsection (a) of this section in cigarette

21 advertising shall comply with the standards set forth

22 in this paragraph. For press and poster advertise23 ments, each such statement and (where applicable)

24 any required statement relating to tar, nicotine, or

25 other constituent yield shall comprise at least 20
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1 percent of the area of the advertisement and shall

2 appear in a conspicuous and prominent format and

3 location at the top of each advertisement within the

4 trim area. The Secretary may revise the required

5 type sizes in such area in such manner as the Sec6 retary determines appropriate. The word ‘‘WARN7 ING’’ shall appear in capital letters, and each label

8 statement shall appear in conspicuous and legible

9 type. The text of the label statement shall be black

10 if the background is white and white if the back11 ground is black, under the plan submitted under

12 paragraph (4) of this subsection. The label state13 ments shall be enclosed by a rectangular border that

14 is the same color as the letters of the statements

15 and that is the width of the first downstroke of the

16 capital ‘‘W’’ of the word ‘‘WARNING’’ in the label

17 statements. The text of such label statements shall

18 be in a typeface pro rata to the following require19 ments: 45-point type for a whole-page broadsheet

20 newspaper advertisement; 39-point type for a half21 page broadsheet newspaper advertisement; 39-point

22 type for a whole-page tabloid newspaper advertise23 ment; 27-point type for a half-page tabloid news24 paper advertisement; 31.5-point type for a double

25 page spread magazine or whole-page magazine ad-
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1 vertisement; 22.5-point type for a 28 centimeter by

2 3 column advertisement; and 15-point type for a 20

3 centimeter by 2 column advertisement. The label

4 statements shall be in English, except that in the

5 case of—

6 ‘‘(A) an advertisement that appears in a

7 newspaper, magazine, periodical, or other publi8 cation that is not in English, the statements

9 shall appear in the predominant language of the

10 publication; and

11 ‘‘(B) in the case of any other advertise12 ment that is not in English, the statements

13 shall appear in the same language as that prin14 cipally used in the advertisement.

15 ‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec16 retary may, through a rulemaking under section 553

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

18 type sizes for the label statements required by this

19 section or the text, format, and type sizes of any re20 quired tar, nicotine yield, or other constituent disclo21 sures, or to establish the text, format, and type sizes

22 for any other disclosures required under the Federal

23 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et.

24 seq.). The text of any such label statements or dis25 closures shall be required to appear only within the
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1 20 percent area of cigarette advertisements provided

2 by paragraph (2) of this subsection. The Secretary

3 shall promulgate regulations which provide for ad4 justments in the format and type sizes of any text

5 required to appear in such area to ensure that the

6 total text required to appear by law will fit within

7 such area.

8 ‘‘(4) MARKETING REQUIREMENTS.—

9 ‘‘(A) The label statements specified in sub10 section (a)(1) shall be randomly displayed in

11 each 12-month period, in as equal a number of

12 times as is possible on each brand of the prod13 uct and be randomly distributed in all areas of

14 the United States in which the product is mar15 keted in accordance with a plan submitted by

16 the tobacco product manufacturer, importer,

17 distributor, or retailer and approved by the Sec18 retary.

19 ‘‘(B) The label statements specified in sub20 section (a)(1) shall be rotated quarterly in al21 ternating sequence in advertisements for each

22 brand of cigarettes in accordance with a plan

23 submitted by the tobacco product manufacturer,

24 importer, distributor, or retailer to, and ap25 proved by, the Secretary.
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1 ‘‘(C) The Secretary shall review each plan

2 submitted under subparagraph (B) and approve

3 it if the plan—

4 ‘‘(i) will provide for the equal distribu5 tion and display on packaging and the ro6 tation required in advertising under this

7 subsection; and

8 ‘‘(ii) assures that all of the labels re9 quired under this section will be displayed

10 by the tobacco product manufacturer, im11 porter, distributor, or retailer at the same

12 time.’’.

13 (b) REPEAL OF PROHIBITION ON STATE RESTRIC14 TION.—Section 5 of the Federal Cigarette Labeling and

15 Advertising Act (15 U.S.C. 1334) is amended—

16 (1) by striking ‘‘(a) ADDITIONAL STATE17 MENTS.—’’ in subsection (a); and

18 (2) by striking subsection (b).

19 SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING

20 LABEL STATEMENTS.

21 Section 4 of the Federal Cigarette Labeling and Ad22 vertising Act ( 15 U.S.C. 1333), as amended by section

23 301 of this title, is further amended by adding at the end

24 the following:
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1 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec2 retary may, by a rulemaking conducted under section 553

3 of title 5, United States Code, adjust the format, type size,

4 and text of any of the warning label statements required

5 by subsection (a) of this section, or establish the format,

6 type size, and text of any other disclosures required under

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301

8 et seq.), if the Secretary finds that such a change would

9 promote greater public understanding of the risks associ10 ated with the use of smokeless tobacco products.’’.

11 SEC. 203. SMOKELESS TOBACCO LABELS AND ADVERTISING

12 WARNINGS.

13 Section 3 of the Comprehensive Smokeless Tobacco

14 Health Education Act of 1986 (15 U.S.C. 4402) is amend15 ed to read as follows:

16 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING.

17 ‘‘(a) GENERAL RULE.—

18 ‘‘(1) It shall be unlawful for any person to man19 ufacture, package, or import for sale or distribution

20 within the United States any smokeless tobacco

21 product unless the product package bears, in accord22 ance with the requirements of this Act, one of the

23 following labels:

24 ‘‘WARNING: This product can cause mouth cancer’’
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1 ‘‘WARNING: This product can cause gum disease

2 and tooth loss’’

3 ‘‘WARNING: This product is not a safe alternative

4 to cigarettes’’

5 ‘‘WARNING: Smokeless tobacco is addictive’’

6 ‘‘(2) Each label statement required by para7 graph (1) shall be—

8 ‘‘(A) located on the 2 principal display

9 panels of the package, and each label statement

10 shall comprise at least 25 percent of each such

11 display panel; and

12 ‘‘(B) in 17-point conspicuous and legible

13 type and in black text on a white background,

14 or white text on a black background, in a man15 ner that contrasts by typography, layout, or

16 color, with all other printed material on the

17 package, in an alternating fashion under the

18 plan submitted under subsection (b)(3), except

19 that if the text of a label statement would oc20 cupy more than 70 percent of the area specified

21 by subparagraph (A), such text may appear in

22 a smaller type size, so long as at least 60 per23 cent of such warning area is occupied by the

24 label statement.
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1 ‘‘(3) The label statements required by para2 graph (1) shall be introduced by each tobacco prod3 uct manufacturer, packager, importer, distributor, or

4 retailer of smokeless tobacco products concurrently

5 into the distribution chain of such products.

6 ‘‘(4) The provisions of this subsection do not

7 apply to a tobacco product manufacturer or dis8 tributor of any smokeless tobacco product that does

9 not manufacture, package, or import smokeless to10 bacco products for sale or distribution within the

11 United States.

12 ‘‘(b) REQUIRED LABELS.—

13 ‘‘(1) It shall be unlawful for any tobacco prod14 uct manufacturer, packager, importer, distributor, or

15 retailer of smokeless tobacco products to advertise or

16 cause to be advertised within the United States any

17 smokeless tobacco product unless its advertising

18 bears, in accordance with the requirements of this

19 section, one of the labels specified in subsection (a).

20 ‘‘(2) Each label statement required by sub21 section (a) in smokeless tobacco advertising shall

22 comply with the standards set forth in this para23 graph. For press and poster advertisements, each

24 such statement and (where applicable) any required
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1 statement relating to tar, nicotine, or other con2 stituent yield shall—

3 ‘‘(A) comprise at least 20 percent of the

4 area of the advertisement, and the warning area

5 shall be delineated by a dividing line of con6 trasting color from the advertisement; and

7 ‘‘(B) the word ‘‘WARNING’’ shall appear

8 in capital letters and each label statement shall

9 appear in conspicuous and legible type. The text

10 of the label statement shall be black on a white

11 background, or white on a black background, in

12 an alternating fashion under the plan submitted

13 under paragraph (3).

14 ‘‘(3)(A) The label statements specified in sub15 section (a)(1) shall be randomly displayed in each

16 12-month period, in as equal a number of times as

17 is possible on each brand of the product and be ran18 domly distributed in all areas of the United States

19 in which the product is marketed in accordance with

20 a plan submitted by the tobacco product manufac21 turer, importer, distributor, or retailer and approved

22 by the Secretary.

23 ‘‘(B) The label statements specified in sub24 section (a)(1) shall be rotated quarterly in alter25 nating sequence in advertisements for each brand of
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1 smokeless tobacco product in accordance with a plan

2 submitted by the tobacco product manufacturer, im3 porter, distributor, or retailer to, and approved by,

4 the Secretary.

5 ‘‘(C) The Secretary shall review each plan sub6 mitted under subparagraph (B) and approve it if the

7 plan—

8 ‘‘(i) will provide for the equal distribution

9 and display on packaging and the rotation re10 quired in advertising under this subsection; and

11 ‘‘(ii) assures that all of the labels required

12 under this section will be displayed by the to13 bacco product manufacturer, importer, dis14 tributor, or retailer at the same time.

15 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is

16 unlawful to advertise smokeless tobacco on any medium

17 of electronic communications subject to the jurisdiction of

18 the Federal Communications Commission.’’.

19 SEC. 204. AUTHORITY TO REVISE SMOKELESS TOBACCO

20 PRODUCT WARNING LABEL STATEMENTS.

21 Section 3 of, as amended by section 303 of this title,

22 is further amended by adding at the end the following:

23 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

24 STATEMENTS.—The Secretary may, by a rulemaking con25 ducted under section 553 of title 5, United States Code,
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1 adjust the format, type size, and text of any of the warn2 ing label statements required by subsection (a) of this sec3 tion, or establish the format, type size, and text of any

4 other disclosures required under the Federal Food, Drug,

5 and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary

6 finds that such a change would promote greater public un7 derstanding of the risks associated with the use of smoke8 less tobacco products.’’.

9 SEC. 205. TAR, NICOTINE, AND OTHER SMOKE CON10 STITUENT DISCLOSURE TO THE PUBLIC.

11 Section 4(a) of the Federal Cigarette Labeling and

12 Advertising Act (15 U.S.C. 1333 (a)), as amended by sec13 tion 301 of this title, is further amended by adding at

14 the end the following:

15 ‘‘(4)(A) The Secretary shall, by a rulemaking

16 conducted under section 553 of title 5, United

17 States Code, determine (in the Secretary’s sole dis18 cretion) whether cigarette and other tobacco product

19 manufacturers shall be required to include in the

20 area of each cigarette advertisement specified by

21 subsection (b) of this section, or on the package

22 label, or both, the tar and nicotine yields of the ad23 vertised or packaged brand. Any such disclosure

24 shall be in accordance with the methodology estab25 lished under such regulations, shall conform to the
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1 type size requirements of subsection (b) of this sec2 tion, and shall appear within the area specified in

3 subsection (b) of this section.

4 ‘‘(B) Any differences between the requirements

5 established by the Secretary under subparagraph (A)

6 and tar and nicotine yield reporting requirements es7 tablished by the Federal Trade Commission shall be

8 resolved by a memorandum of understanding be9 tween the Secretary and the Federal Trade Commis10 sion.

11 ‘‘(C) In addition to the disclosures required by

12 subparagraph (A) of this paragraph, the Secretary

13 may, under a rulemaking conducted under section

14 553 of title 5, United States Code, prescribe disclo15 sure requirements regarding the level of any ciga16 rette or other tobacco product smoke constituent.

17 Any such disclosure may be required if the Secretary

18 determines that disclosure would be of benefit to the

19 public health, or otherwise would increase consumer

20 awareness of the health consequences of the use of

21 tobacco products, except that no such prescribed dis22 closure shall be required on the face of any cigarette

23 package or advertisement. Nothing in this section

24 shall prohibit the Secretary from requiring such pre25 scribed disclosure through a cigarette or other to-
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1 bacco product package or advertisement insert, or by

2 any other means under the Federal Food, Drug, and

3 Cosmetic Act (21 U.S.C. 301 et seq.).’’.

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