II

106TH CONGRESS

2D SESSION S. 2566

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

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

IN THE SENATE OF THE UNITED STATES

MAY 16, 2000

Mr. FRIST (for himself and Mr. MCCAIN) introduced the following bill; which

was read twice and referred to the Committee on Health, Education,

Labor, and Pensions

A BILL

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

grant the Secretary of Health and Human Services the

authority to regulate tobacco products, and for other

purposes.

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

3 SECTION 1. SHORT TITLE.

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

6 SEC. 2. FINDINGS.

7 The Congress finds the following:
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1 (1) The use of tobacco products by the Nation’s

2 children is a pediatric disease of epic proportions

3 that results in new generations of tobacco-dependent

4 children and adults.

5 (2) A consensus exists within the scientific and

6 medical communities that tobacco products are in7 herently dangerous and cause cancer, heart disease,

8 and other serious adverse health effects.

9 (3) Nicotine is addictive.

10 (4) Virtually all new users of tobacco products

11 are under the minimum legal age to purchase such

12 products.

13 (5) Tobacco advertising and marketing con14 tribute significantly to the use of nicotine-containing

15 tobacco products by adolescents.

16 (6) Because past efforts to restrict advertising

17 and marketing of tobacco products have failed ade18 quately to curb tobacco use by adolescents, com19 prehensive restrictions on the sale, promotion, and

20 distribution of such products are needed.

21 (7) Federal and State governments have lacked

22 the legal and regulatory authority and resources

23 they need to address comprehensively the public

24 health and societal problems caused by the use of to25 bacco products.
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1 (8) Federal and State public health officials,

2 the public health community, and the public at large

3 recognize that the tobacco industry should be subject

4 to ongoing oversight.

5 (9) Under article I, section 8 of the Constitu6 tion, the Congress is vested with the responsibility

7 for regulating interstate commerce and commerce

8 with Indian tribes.

9 (10) The sale, distribution, marketing, adver10 tising, and use of tobacco products are activities in

11 and substantially affecting interstate commerce be12 cause they are sold, marketed, advertised, and dis13 tributed in interstate commerce on a nationwide

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

15 economy.

16 (11) The sale, distribution, marketing, adver17 tising, and use of such products substantially affect

18 interstate commerce through the health care and

19 other costs attributable to the use of tobacco prod20 ucts.

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

22 adopt comprehensive public health legislation be23 cause of tobacco’s unique position in the Nation’s

24 history and economy and the need to prevent the

25 sale, distribution, marketing and advertising of to-
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1 bacco products to persons under the minimum legal

2 age to purchase such products.

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

4 equitable, and consistent result that will serve the

5 public interest by restricting throughout the Nation

6 the sale, distribution, marketing, and advertising of

7 tobacco products only to persons of legal age to pur8 chase such products.

9 (14) Public health authorities estimate that the

10 benefits to the Nation of enacting Federal legislation

11 to accomplish these goals would be significant in

12 human and economic terms.

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

14 50 percent would prevent well over 60,000 early

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

16 year in reduced medical costs, improved productivity,

17 and the avoidance of premature deaths.

18 (16) Advertising, marketing, and promotion of

19 tobacco products have been especially directed to at20 tract young persons to use tobacco products and

21 these efforts have resulted in increased use of such

22 products by youth. Past efforts to oversee these ac23 tivities have not been successful in adequately pre24 venting such increased use.
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1 (17) Tobacco advertising increases the size of

2 the tobacco market by increasing consumption of to3 bacco products including increasing tobacco use by

4 young people.

5 (18) Children are more influenced by tobacco

6 advertising than adults and they smoke the most ad7 vertised brands.

8 (19) Tobacco company documents indicate that

9 young people are an important and often crucial seg10 ment of the tobacco market.

11 (20) Advertising restrictions will have a positive

12 effect on the smoking rates of young people.

13 (21) Restrictions on advertising are necessary

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

16 people.

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

18 adopt legislation to address the public health crisis

19 created by actions of the tobacco industry.

20 SEC. 3. DEFINITIONS.

21 In this Act:

22 (1) BRAND.—The term ‘‘brand’’ means a vari23 ety of tobacco product distinguished by the tobacco

24 used, tar content, nicotine content, flavoring used,

25 size, filtration, or packaging, logo, registered trade-
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1 mark or brand name, identifiable pattern of colors,

2 or any combination of such attributes.

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

4 meaning given that term by section 3(1) of the Fed5 eral Cigarette Labeling and Advertising Act (15

6 U.S.C. 1332(1)), but also includes tobacco, in any

7 form, that is functional in the product, which, be8 cause of its appearance, the type of tobacco used in

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

10 be offered to, or purchased by, consumers as a ciga11 rette or as roll-your-own tobacco.

12 (3) CIGARETTE TOBACCO.—The term ‘‘cigarette

13 tobacco’’ means any product that consists of loose

14 tobacco that is intended for use by consumers in a

15 cigarette. Unless otherwise stated, the requirements

16 for cigarettes shall also apply to cigarette tobacco.

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

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

19 Federal Cigarette Labeling and Advertising Act (15

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

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

22 relation to cigarettes means any element of main23 stream or sidestream smoke.

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

25 regards a tobacco product means any person who
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1 furthers the distribution of cigarette or smokeless to2 bacco, whether domestic or imported, at any point

3 from the original place of manufacture to the person

4 who sells or distributes the product to individuals for

5 personal consumption. Common carriers are not con6 sidered distributors for purposes of this Act.

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

8 relation to cigarettes or smokeless tobacco products

9 means any substance, chemical, or compound (other

10 than tobacco, water, or reconstituted tobacco sheet

11 made wholly from tobacco) added, or specified for

12 addition, by the manufacturer to the tobacco, paper,

13 or filter of a cigarette, or to the tobacco of a smoke14 less tobacco product, including flavorants, processing

15 aids, casing sauces, preservatives, and combustion

16 modifiers.

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

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

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

20 any salt or complex of nicotine.

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

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

23 other container, any wrapping (including cello24 phane), in which cigarettes or smokeless tobacco are
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1 offered for sale, sold, or otherwise distributed to con2 sumers.

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

4 any person who sells cigarettes or smokeless tobacco

5 to individuals for personal consumption, or who op6 erates a facility where self-service displays of tobacco

7 products are permitted.

8 (11) SECRETARY.—Except where the context

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

10 Secretary of Health and Human Services.

11 (12) SMOKELESS TOBACCO.—The term ‘‘smoke12 less tobacco’’ means any product that consists of

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

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

15 SEC. 4. AMENDMENT OF FEDERAL FOOD, DRUG, AND COS16 METIC ACT OF 1938.

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

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

19 adding at the end the following:

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

21 product made or derived from tobacco that is in22 tended for human consumption, including any com23 ponent, part, or accessory of a tobacco product (ex24 cept for raw materials other than tobacco used in
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1 manufacturing a component, part, or accessory of a

2 tobacco product).’’.

3 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.—

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

5 301 et seq.) is amended—

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

7 (2) by redesignating sections 901 through 907

8 as sections 1001 through 1007; and

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

10 ‘‘CHAPTER IX—TOBACCO

11 PRODUCTS

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), unless the

22 product is a reduced risk product pursuant to sec23 tion 912.

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

25 tobacco products subject to the provisions of part 897 of
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1 title 21, Code of Federal Regulations, and to any other

2 tobacco products that the Secretary by regulation deems

3 to be subject to this chapter.

4 ‘‘(c) SCOPE.—

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

6 to affect the Secretary’s authority over, or the regu7 lation of, products under this Act that are not to8 bacco products under chapter V of the Federal

9 Food, Drug and Cosmetic Act or any other chapter

10 of that Act.

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

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

13 the manufacturer, or to the producers of tobacco

14 leaf, including tobacco growers, tobacco warehouses,

15 and tobacco grower cooperatives, nor shall any em16 ployee of the Food and Drug Administration have

17 any authority whatsoever to enter onto a farm

18 owned by a producer of tobacco leaf without the

19 written consent of such producer. Notwithstanding

20 any other provision of this subparagraph, if a pro21 ducer of tobacco leaf is also a tobacco product man22 ufacturer or controlled by a tobacco product manu23 facturer, the producer shall be subject to this chap24 ter in the producer’s capacity as a manufacturer.

25 Nothing in this chapter shall be construed to grant
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1 the Secretary authority to promulgate regulations on

2 any matter that involves the production of tobacco

3 leaf or a producer thereof, other than activities by

4 a manufacturer affecting production. For purposes

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

6 means a member of the same controlled group of

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

8 of the Internal Revenue Code of 1986, or under

9 common control within the meaning of the regula10 tions promulgated under section 52(b) of such Code.

11 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS.

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

13 if—

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

15 putrid, or decomposed substance, or is otherwise

16 contaminated by any poisonous or deleterious sub17 stance that may render the product more injurious

18 to health;

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

20 under insanitary conditions whereby it may have

21 been contaminated with filth, or whereby it may

22 have been rendered more injurious to health;

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

24 part, of any poisonous or deleterious substance
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1 which may render the contents more injurious to

2 health;

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

4 as, a tobacco product which is subject to a perform5 ance standard established under section 907 unless

6 such tobacco product is in all respects in conformity

7 with such standard;

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

9 premarket approval, is not exempt under section

10 906(f), and does not have an approved application in

11 effect;

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

13 controls used for, its manufacture, packing or stor14 age are not in conformity with applicable require15 ments under section 906(e)(1) or an applicable con16 dition prescribed by an order under section

17 906(e)(2); or

18 ‘‘(7) it is a tobacco product for which an ex19 emption has been granted under section 906(f) for

20 investigational use and the person who was granted

21 such exemption or any investigator who uses such

22 tobacco product under such exemption fails to com23 ply with a requirement prescribed by or under such

24 section.
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1 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS.

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

3 deemed to be misbranded—

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

5 particular;

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

7 containing—

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

9 tobacco product manufacturer, packer, or dis10 tributor; and

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

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

13 numerical count,

14 except that under subparagraph (B) of this para15 graph reasonable variations shall be permitted, and

16 exemptions as to small packages shall be established,

17 by regulations prescribed by the Secretary;

18 ‘‘(3) if any word, statement, or other informa19 tion required by or under authority of this chapter

20 to appear on the label or labeling is not prominently

21 placed thereon with such conspicuousness (as com22 pared with other words, statements or designs in the

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

24 be read and understood by the ordinary individual

25 under customary conditions of purchase and use;
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1 ‘‘(4) if it has an established name, unless its

2 label bears, to the exclusion of any other nonpropri3 etary name, its established name prominently print4 ed in type as required by the Secretary by regula5 tion;

6 ‘‘(5) if the Secretary has issued regulations re7 quiring that its labeling bear adequate directions for

8 use, or adequate warnings against use by children,

9 that are necessary for the protection of users unless

10 its labeling conforms in all respects to such regula11 tions;

12 ‘‘(6) if it was manufactured, prepared, propa13 gated, compounded, or processed in any State in an

14 establishment not duly registered under section

15 905(b), if it was not included in a list required by

16 section 905(i), if a notice or other information re17 specting it was not provided as required by such sec18 tion or section 905(j), or if it does not bear such

19 symbols from the uniform system for identification

20 of tobacco products prescribed under section 905(e)

21 as the Secretary by regulation requires;

22 ‘‘(7) if, in the case of any tobacco product dis23 tributed or offered for sale in any State—

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

25 in any particular; or
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1 ‘‘(B) it is sold, distributed, or used in vio2 lation of regulations prescribed under section

3 906(d);

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

5 distributed or offered for sale in any State, the man6 ufacturer, packer, or distributor thereof includes in

7 all advertisements and other descriptive printed mat8 ter issued or caused to be issued by the manufac9 turer, packer, or distributor with respect to that to10 bacco product—

11 ‘‘(A) a true statement of the tobacco prod12 uct’s established name as defined in paragraph

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

14 ‘‘(B) a brief statement of—

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

16 and relevant warnings, precautions, side

17 effects, and contraindications; and

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

19 products made subject to a finding by the

20 Secretary after notice and opportunity for

21 comment that such action is necessary to

22 protect the public health, a full description

23 of the components of such tobacco product

24 or the formula showing quantitatively each

25 ingredient of such tobacco product to the
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1 extent required in regulations which shall

2 be issued by the Secretary after an oppor3 tunity for a hearing;

4 ‘‘(9) if it is a tobacco product subject to a per5 formance standard established under section 907,

6 unless it bears such labeling as may be prescribed in

7 such performance standard; or

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

9 ‘‘(A) to comply with any requirement pre10 scribed under section 904 or 908; or

11 ‘‘(B) to furnish any material or informa12 tion required by or under section 909.

13 ‘‘(b) PRIOR APPROVAL OF STATEMENTS ON

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

15 approval of statements made on the label of a tobacco

16 product. No regulation issued under this subsection may

17 require prior approval by the Secretary of the content of

18 any advertisement and no advertisement of a tobacco

19 product, published after the date of enactment of this Act

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

21 or covered by regulations issued hereunder, be subject to

22 the provisions of sections 12 through 15 of the Federal

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

24 subsection does not apply to any printed matter which the
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1 Secretary determines to be labeling as defined in section

2 201(m).

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

4 SECRETARY.

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

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

7 manufacturer or importer of tobacco products, or agents

8 thereof, shall submit to the Secretary the following infor9 mation:

10 ‘‘(1) A listing of all tobacco ingredients, sub11 stances and compounds that are, on such date,

12 added by the manufacturer to the tobacco, paper, fil13 ter, or other component of each tobacco product by

14 brand and by quantity in each brand and subbrand.

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

16 form of nicotine in each tobacco product measured

17 in milligrams of nicotine.

18 ‘‘(3) All documents (including underlying sci19 entific information) relating to research activities,

20 and research findings, conducted, supported, or pos21 sessed by the manufacturer (or agents thereof) on

22 the health, behavioral, or physiologic effects of to23 bacco products, their constituents, ingredients, and

24 components, and tobacco additives, described in

25 paragraph (1).
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1 ‘‘(4) 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) that

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

6 health from tobacco products can occur upon the

7 employment of technology available or known to the

8 manufacturer.

9 ‘‘(5) All documents (including underlying sci10 entific information) relating to marketing research

11 involving the use of tobacco products.

12 An importer of a tobacco product not manufactured in the

13 United States shall supply the information required of a

14 tobacco product manufacturer under this subsection.

15 ‘‘(b) ANNUAL SUBMISSION.—A tobacco product man16 ufacturer or importer that is required to submit informa17 tion under subsection (a) shall update such information

18 on an annual basis under a schedule determined by the

19 Secretary.

20 ‘‘(c) TIME FOR SUBMISSION.—

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

22 to the delivery for introduction into interstate com23 merce of a tobacco product not on the market on the

24 date of enactment of this chapter, the manufacturer

25 of such product shall provide the information re-
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1 quired under subsection (a) and such product shall

2 be subject to the annual submission under sub3 section (b).

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

5 If at any time a tobacco product manufacturer adds

6 to its tobacco products a new tobacco additive, in7 creases or decreases the quantity of an existing to8 bacco additive or the nicotine content, delivery, or

9 form, or eliminates a tobacco additive from any to10 bacco product, the manufacturer shall within 60

11 days of such action so advise the Secretary in writ12 ing and reference such modification in submissions

13 made under subsection (b).

14 ‘‘SEC. 905. ANNUAL REGISTRATION.

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

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

17 901(c)(2), the term ‘manufacture, preparation,

18 compounding, or processing’ shall include repack19 aging or otherwise changing the container, wrapper,

20 or labeling of any tobacco product package in fur21 therance of the distribution of the tobacco product

22 from the original place of manufacture to the person

23 who makes final delivery or sale to the ultimate con24 sumer or user; and
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1 ‘‘(2) the term ‘name’ shall include in the case

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

3 the case of a corporation, the name of each cor4 porate officer and director, and the State of incorpo5 ration.

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

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

8 owns or operates any establishment in any State engaged

9 in the manufacture, preparation, compounding, or proc10 essing of a tobacco product or tobacco products shall reg11 ister with the Secretary the name, places of business, and

12 all such establishments of that person.

13 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA14 TORS.—Every person upon first engaging in the manufac15 ture, preparation, compounding, or processing of a tobacco

16 product or tobacco products in any establishment owned

17 or operated in any State by that person shall immediately

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

19 business, and such establishment.

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

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

22 (c) shall immediately register with the Secretary any addi23 tional establishment which that person owns or operates

24 in any State and in which that person begins the manufac-
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1 ture, preparation, compounding, or processing of a tobacco

2 product or tobacco products.

3 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS4 TEM.—The Secretary may by regulation prescribe a uni5 form system for the identification of tobacco products and

6 may require that persons who are required to list such

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

8 list such tobacco products in accordance with such system.

9 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA10 TION.—The Secretary shall make available for inspection,

11 to any person so requesting, any registration filed under

12 this section.

13 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB14 LISHMENTS.—Every establishment in any State registered

15 with the Secretary under this section shall be subject to

16 inspection under section 704, and every such establish17 ment engaged in the manufacture, compounding, or proc18 essing of a tobacco product or tobacco products shall be

19 so inspected by one or more officers or employees duly

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

21 period beginning with the date of registration of such es22 tablishment under this section and at least once in every

23 successive 2-year period thereafter.

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

25 Any establishment within any foreign country engaged in
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1 the manufacture, preparation, compounding, or processing

2 of a tobacco product or tobacco products, may register

3 under this section under regulations promulgated by the

4 Secretary. Such regulations shall require such establish5 ment to provide the information required by subsection (i)

6 of this section and shall include provisions for registration

7 of any such establishment upon condition that adequate

8 and effective means are available, by arrangement with the

9 government of such foreign country or otherwise, to enable

10 the Secretary to determine from time to time whether to11 bacco products manufactured, prepared, compounded, or

12 processed in such establishment, if imported or offered for

13 import into the United States, shall be refused admission

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

15 ‘‘(i) REGISTRATION INFORMATION.—

16 ‘‘(1) PRODUCT LIST.—Every person who reg17 isters with the Secretary under subsection (b), (c),

18 or (d) of this section shall, at the time of registra19 tion under any such subsection, file with the Sec20 retary a list of all tobacco products which are being

21 manufactured, prepared, compounded, or processed

22 by that person for commercial distribution and

23 which has not been included in any list of tobacco

24 products filed by that person with the Secretary

25 under this paragraph or paragraph (2) before such
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1 time of registration. Such list shall be prepared in

2 such form and manner as the Secretary may pre3 scribe and shall be accompanied by—

4 ‘‘(A) in the case of a tobacco product con5 tained in the applicable list with respect to

6 which a performance standard has been estab7 lished under section 907 or which is subject to

8 section 910, a reference to the authority for the

9 marketing of such tobacco product and a copy

10 of all labeling for such tobacco product;

11 ‘‘(B) in the case of any other tobacco prod12 uct contained in an applicable list, a copy of all

13 consumer information and other labeling for

14 such tobacco product, a representative sampling

15 of advertisements for such tobacco product,

16 and, upon request made by the Secretary for

17 good cause, a copy of all advertisements for a

18 particular tobacco product; and

19 ‘‘(C) if the registrant filing a list has de20 termined that a tobacco product contained in

21 such list is not subject to a performance stand22 ard established under section 907, a brief state23 ment of the basis upon which the registrant

24 made such determination if the Secretary re-
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1 quests such a statement with respect to that

2 particular tobacco product.

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

4 PRODUCT LIST.—Each person who registers with the

5 Secretary under this section shall report to the Sec6 retary once during the month of June of each year

7 and once during the month of December of each

8 year the following:

9 ‘‘(A) A list of each tobacco product intro10 duced by the registrant for commercial distribu11 tion which has not been included in any list

12 previously filed by that person with the Sec13 retary under this subparagraph or paragraph

14 (1) of this subsection. A list under this sub15 paragraph shall list a tobacco product by its es16 tablished name and shall be accompanied by the

17 other information required by paragraph (1).

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

19 made a report under this paragraph that person

20 has discontinued the manufacture, preparation,

21 compounding, or processing for commercial dis22 tribution of a tobacco product included in a list

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

24 notice of such discontinuance, the date of such
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1 discontinuance, and the identity of its estab2 lished name.

3 ‘‘(C) If since the date the registrant re4 ported under subparagraph (B) a notice of dis5 continuance that person has resumed the manu6 facture, preparation, compounding, or proc7 essing for commercial distribution of the to8 bacco product with respect to which such notice

9 of discontinuance was reported, notice of such

10 resumption, the date of such resumption, the

11 identity of such tobacco product by established

12 name, and other information required by para13 graph (1), unless the registrant has previously

14 reported such resumption to the Secretary

15 under this subparagraph.

16 ‘‘(D) Any material change in any informa17 tion previously submitted under this paragraph

18 or paragraph (1).

19 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER20 TAIN SUBSTANTIALLY EQUIVALENT PRODUCTS INTO

21 INTERSTATE COMMERCE.—Each person who is required

22 to register under this section and who proposes to begin

23 the introduction or delivery for introduction into interstate

24 commerce for commercial distribution of a tobacco product

25 intended for human use that was not commercially mar-
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1 keted (other than for test marketing) in the United States

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

3 Secretary by regulation shall, at least 90 days before mak4 ing such introduction or delivery, report to the Secretary

5 (in such form and manner as the Secretary shall by regu6 lation prescribe)—

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

8 that the tobacco product is substantially equivalent,

9 within the meaning of section 910, to a tobacco

10 product commercially marketed (other than for test

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

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

13 requirements of this Act; and

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

15 with the requirements under section 907 that are

16 applicable to the tobacco product.

17 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL

18 OF TOBACCO PRODUCTS.

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

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

21 tobacco product shall apply to such tobacco product until

22 the applicability of the requirement to the tobacco product

23 has been changed by action taken under section 907, sec24 tion 910, or subsection (d) of this section, and any re25 quirement established by or under section 902, 903, 905,
27

•S 2566 IS

1 or 909 which is inconsistent with a requirement imposed

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

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

4 tobacco product.

5 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM6 MENT.—Each notice of proposed rulemaking under section

7 907, 908, 909, or 910, or under this section, any other

8 notice which is published in the Federal Register with re9 spect to any other action taken under any such section

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

11 publication of findings required to be made in connection

12 with rulemaking under any such section shall set forth—

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

14 may examine data and other information on which

15 the notice or findings is based; and

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

17 may present their comments on the notice or find18 ings (including the need thereof) orally or in writing,

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

20 exceed 90 days unless the time is extended by the

21 Secretary by a notice published in the Federal Reg22 ister stating good cause therefore.

23 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA24 TION.—Any information reported to or otherwise obtained

25 by the Secretary or the Secretary’s representative under
28

•S 2566 IS

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

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

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

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

5 that section shall be considered confidential and shall not

6 be disclosed, except that the information may be disclosed

7 to other officers or employees concerned with carrying out

8 this chapter, or when relevant in any proceeding under

9 this chapter.

10 ‘‘(d) RESTRICTIONS.—

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

12 that a tobacco product be restricted to sale or dis13 tribution upon such conditions, including restrictions

14 on the access to, and the advertising and promotion

15 of, the tobacco product, as the Secretary may pre16 scribe in such regulation if the Secretary determines

17 that such regulation would be appropriate for the

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

19 products by children under the age at which tobacco

20 products may be legally purchased. No such condi21 tion may require that the sale or distribution of a

22 tobacco product be limited to the written or oral au23 thorization of a practitioner licensed by law to pre24 scribe medical products.
29

•S 2566 IS

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

2 such appropriate statements of the restrictions re3 quired by a regulation under subsection (a) as the

4 Secretary may in such regulation prescribe.

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

6 prohibit the sale of any tobacco product in face-to

7 face transactions by a specific category of retail out8 lets.

9 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE10 MENTS.—

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

12 CONFORM.—

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

14 with subparagraph (B), prescribe regulations

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

17 pre-production design validation (including a

18 process to assess the performance of a tobacco

19 product), packing and storage of a tobacco

20 product, conform to current good manufac21 turing practice for an agricultural product, as

22 prescribed in such regulations, to assure that

23 the public health is protected and that the to24 bacco product is in compliance with this chap25 ter.
30

•S 2566 IS

1 ‘‘(B) The Secretary shall—

2 ‘‘(i) before promulgating any regula3 tion under subparagraph (A), afford an ad4 visory committee an opportunity to submit

5 recommendations with respect to the regu6 lation proposed to be promulgated;

7 ‘‘(ii) before promulgating any regula8 tion under subparagraph (A), afford oppor9 tunity for an oral hearing;

10 ‘‘(iii) provide the advisory committee a

11 reasonable time to make its recommenda12 tion with respect to proposed regulations

13 under subparagraph (A); and

14 ‘‘(iv) in establishing the effective date

15 of a regulation promulgated under this

16 subsection, take into account the dif17 ferences in the manner in which the dif18 ferent types of tobacco products have his19 torically been produced, the financial re20 sources of the different tobacco product

21 manufacturers, and the state of their exist22 ing manufacturing facilities; and shall pro23 vide for a reasonable period of time for

24 such manufacturers to conform to good

25 manufacturing practices.
31

•S 2566 IS

1 ‘‘(2) EXEMPTIONS; VARIANCES.—

2 ‘‘(A) Any person subject to any require3 ment prescribed under paragraph (1) may peti4 tion the Secretary for a permanent or tem5 porary exemption or variance from such re6 quirement. Such a petition shall be submitted

7 to the Secretary in such form and manner as

8 the Secretary shall prescribe and shall—

9 ‘‘(i) in the case of a petition for an ex10 emption from a requirement, set forth the

11 basis for the petitioner’s determination

12 that compliance with the requirement is

13 not required to assure that the tobacco

14 product will be in compliance with this

15 chapter;

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

17 variance from a requirement, set forth the

18 methods proposed to be used in, and the

19 facilities and controls proposed to be used

20 for, the manufacture, packing, and storage

21 of the tobacco product in lieu of the meth22 ods, facilities, and controls prescribed by

23 the requirement; and

24 ‘‘(iii) contain such other information

25 as the Secretary shall prescribe.
32

•S 2566 IS

1 ‘‘(B) The Secretary may refer to an advi2 sory committee any petition submitted under

3 subparagraph (A). The advisory committee

4 shall report its recommendations to the Sec5 retary with respect to a petition referred to it

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

7 referral. Within 60 days after—

8 ‘‘(i) the date the petition was sub9 mitted to the Secretary under subpara10 graph (A); or

11 ‘‘(ii) the day after the petition was re12 ferred to an advisory committee,

13 whichever occurs later, the Secretary shall by

14 order either deny the petition or approve it.

15 ‘‘(C) The Secretary may approve—

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

17 tobacco product from a requirement if the

18 Secretary determines that compliance with

19 such requirement is not required to assure

20 that the tobacco product will be in compli21 ance with this chapter; and

22 ‘‘(ii) a petition for a variance for a to23 bacco product from a requirement if the

24 Secretary determines that the methods to

25 be used in, and the facilities and controls
33

•S 2566 IS

1 to be used for, the manufacture, packing,

2 and storage of the tobacco product in lieu

3 of the methods, controls, and facilities pre4 scribed by the requirement are sufficient to

5 assure that the tobacco product will be in

6 compliance with this chapter.

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

8 a petition for a variance shall prescribe such

9 conditions respecting the methods used in, and

10 the facilities and controls used for, the manu11 facture, packing, and storage of the tobacco

12 product to be granted the variance under the

13 petition as may be necessary to assure that the

14 tobacco product will be in compliance with this

15 chapter.

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

17 subparagraph (B) respecting a petition, the pe18 titioner shall have an opportunity for an infor19 mal hearing on such order.

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

21 Secretary may exempt tobacco products intended for in22 vestigational use from this chapter under such conditions

23 as the Secretary may prescribe by regulation.

24 ‘‘(g) RESEARCH AND DEVELOPMENT.—The Sec25 retary may enter into contracts for research, testing, and
34

•S 2566 IS

1 demonstrations respecting tobacco products and may ob2 tain tobacco products for research, testing, and dem3 onstration purposes without regard to section 3324(a) and

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

5 41, United States Code.

6 ‘‘SEC. 907. PERFORMANCE STANDARDS.

7 ‘‘(a) IN GENERAL.—

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

9 adopt performance standards for a tobacco product

10 if the Secretary finds that a performance standard

11 is appropriate for the protection of the public health.

12 This finding shall be determined with respect to the

13 risks and benefits to the population as a whole, in14 cluding users and non-users of the tobacco product,

15 and taking into account—

16 ‘‘(A) the increased or decreased likelihood

17 that existing users of tobacco products will stop

18 using such products; and

19 ‘‘(B) the increased or decreased likelihood

20 that those who do not use tobacco products will

21 start using such products.

22 ‘‘(2) CONTENT OF PERFORMANCE STAND23 ARDS.—A performance standard established under

24 this section for a tobacco product—
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•S 2566 IS

1 ‘‘(A) shall include provisions to provide

2 performance that is appropriate for the protec3 tion of the public health, including provisions,

4 where appropriate—

5 ‘‘(i) for the reduction of nicotine

6 yields of the product;

7 ‘‘(ii) for the reduction or elimination

8 of other harmful constituents or harmful

9 components of the product; or

10 ‘‘(iii) relating to any other require11 ment under (B);

12 ‘‘(B) shall, where necessary to be appro13 priate for the protection of the public health,

14 include—

15 ‘‘(i) provisions respecting the con16 struction, components, ingredients, and

17 properties of the tobacco product;

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

19 sample basis or, if necessary, on an indi20 vidual basis) of the tobacco product;

21 ‘‘(iii) provisions for the measurement

22 of the performance characteristics of the

23 tobacco product; and

24 ‘‘(iv) provisions requiring that the re25 sults of each or of certain of the tests of
36

•S 2566 IS

1 the tobacco product required to be made

2 under clause (ii) show that the tobacco

3 product is in conformity with the portions

4 of the standard for which the test or tests

5 were required; and

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

7 unacceptable for adult consumption.

8 ‘‘(3) PERIODIC REEVALUATION OF PERFORM9 ANCE STANDARDS.—The Secretary shall provide for

10 periodic evaluation of performance standards estab11 lished under this section to determine whether such

12 standards should be changed to reflect new medical,

13 scientific, or other technological data. The Secretary

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

15 person.

16 ‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN17 FORMED PERSONS.—In carrying out duties under

18 this section, the Secretary shall, to the maximum ex19 tent practicable—

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

21 technical support available in other Federal

22 agencies;

23 ‘‘(B) consult with other Federal agencies

24 concerned with standard-setting and other na-
37

•S 2566 IS

1 tionally or internationally recognized standard2 setting entities; and

3 ‘‘(C) invite appropriate participation,

4 through joint or other conferences, workshops,

5 or other means, by informed persons represent6 ative of scientific, professional, industry, or con7 sumer organizations who in the Secretary’s

8 judgment can make a significant contribution.

9 ‘‘(b) ESTABLISHMENT OF STANDARDS.—

10 ‘‘(1) NOTICE.—

11 (A) The Secretary shall publish in the

12 Federal Register a notice of proposed rule13 making for the establishment, amendment, or

14 revocation of any performance standard for a

15 tobacco product.

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

17 the establishment or amendment of a perform18 ance standard for a tobacco product shall—

19 ‘‘(i) set forth a finding with sup20 porting justification that the performance

21 standard is appropriate for the protection

22 of the public health;

23 ‘‘(ii) set forth proposed findings with

24 respect to the risk of illness or injury that
38

•S 2566 IS

1 the performance standard is intended to

2 reduce or eliminate; and

3 ‘‘(iii) invite interested persons to sub4 mit an existing performance standard for

5 the tobacco product, including a draft or

6 proposed performance standard, for consid7 eration by the Secretary.

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

9 the revocation of a performance standard shall

10 set forth a finding with supporting justification

11 that the performance standard is no longer nec12 essary to be appropriate for the protection of

13 the public health.

14 ‘‘(D) The Secretary shall consider all infor15 mation submitted in connection with a proposed

16 standard, including information concerning the

17 countervailing effects of the performance stand18 ard on the health of adolescent tobacco users,

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

20 as the creation of a significant demand for con21 traband or other tobacco products that do not

22 meet the requirements of this chapter and the

23 significance of such demand, and shall issue the

24 standard if the Secretary determines that the
39

•S 2566 IS

1 standard would be appropriate for the protec2 tion of the public health.

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

4 comment period of not less than 60 days.

5 ‘‘(2) PROMULGATION.—

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

7 comment on a notice of proposed rulemaking

8 published under paragraph (1) respecting a per9 formance standard and after consideration of

10 such comments and any report from an advi11 sory committee, the Secretary shall—

12 ‘‘(i) promulgate a regulation estab13 lishing a performance standard and pub14 lish in the Federal Register findings on the

15 matters referred to in paragraph (1); or

16 ‘‘(ii) publish a notice terminating the

17 proceeding for the development of the

18 standard together with the reasons for

19 such termination.

20 ‘‘(B) A regulation establishing a perform21 ance standard shall set forth the date or dates

22 upon which the standard shall take effect, but

23 no such regulation may take effect before one

24 year after the date of its publication unless the

25 Secretary determines that an earlier effective
40

•S 2566 IS

1 date is necessary for the protection of the pub2 lic health. Such date or dates shall be estab3 lished so as to minimize, consistent with the

4 public health, economic loss to, and disruption

5 or dislocation of, domestic and international

6 trade.

7 ‘‘(3) POWER RESERVED TO CONGRESS.—Be8 cause of the importance of any decision to issue a

9 regulation establishing a performance standard—

10 ‘‘(A) eliminating all cigarettes, all smoke11 less tobacco products, or any similar class of to12 bacco products, or

13 ‘‘(B) requiring the reduction of nicotine

14 yields of a tobacco product to zero,

15 Congress expressly reserves to itself the power to

16 make such a decision.

17 ‘‘(4) AMENDMENT; REVOCATION.—

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

19 own initiative or upon petition of an interested

20 person may by a regulation, promulgated in ac21 cordance with the requirements of paragraphs

22 (1) and (2)(B) of this subsection, amend or re23 voke a performance standard.

24 ‘‘(B) The Secretary may declare a pro25 posed amendment of a performance standard to
41

•S 2566 IS

1 be effective on and after its publication in the

2 Federal Register and until the effective date of

3 any final action taken on such amendment if

4 the Secretary determines that making it so ef5 fective is in the public interest.

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

7 The Secretary—

8 ‘‘(A) may, on the Secretary’s own initia9 tive, refer a proposed regulation for the estab10 lishment, amendment, or revocation of a per11 formance standard; or

12 ‘‘(B) shall, upon the request of an inter13 ested person which demonstrates good cause for

14 referral and which is made before the expiration

15 of the period for submission of comments on

16 such proposed regulation,

17 refer such proposed regulation to an advisory com18 mittee, for a report and recommendation with re19 spect to any matter involved in the proposed regula20 tion which requires the exercise of scientific judg21 ment. If a proposed regulation is referred under this

22 subparagraph to the advisory committee, the Sec23 retary shall provide the advisory committee with the

24 data and information on which such proposed regu25 lation is based. The advisory committee shall, within
42

•S 2566 IS

1 60 days after the referral of a proposed regulation

2 and after independent study of the data and infor3 mation furnished to it by the Secretary and other

4 data and information before it, submit to the Sec5 retary a report and recommendation respecting such

6 regulation, together with all underlying data and in7 formation and a statement of the reason or basis for

8 the recommendation. A copy of such report and rec9 ommendation shall be made public by the Secretary.

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

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

12 that—

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

14 delivered for introduction into interstate commerce

15 for commercial distribution presents a risk of sub16 stantial harm to the public health exceeding the

17 risks posed by tobacco products marketed before the

18 date of enactment of this Act; and

19 ‘‘(2) notification under this subsection is nec20 essary to eliminate the unreasonable risk of such

21 harm and no more practicable means is available

22 under the provisions of this chapter (other than this

23 section) to eliminate such risk,

24 the Secretary may issue such order as may be necessary

25 to assure that adequate notification is provided in an ap-
43

•S 2566 IS

1 propriate form, by the persons and means best suited

2 under the circumstances involved, to all persons who

3 should properly receive such notification in order to elimi4 nate such risk. The Secretary may order notification by

5 any appropriate means, including public service announce6 ments. Before issuing an order under this subsection, the

7 Secretary shall consult with the persons who are to give

8 notice under the order.

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

10 Compliance with an order issued under this section shall

11 not relieve any person from liability under Federal or

12 State law.

13 ‘‘(c) RECALL AUTHORITY.—

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

15 there is a reasonable probability that a tobacco prod16 uct contains a manufacturing or other defect not or17 dinarily contained in tobacco products on the market

18 that would cause serious, adverse health con19 sequences or death, the Secretary shall issue an

20 order requiring the appropriate person (including

21 the manufacturers, importers, distributors, or retail22 ers of the tobacco product) to immediately cease dis23 tribution of such tobacco product. The order shall

24 provide the person subject to the order with an op25 portunity for an informal hearing, to be held not
44

•S 2566 IS

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

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

3 on whether the order should be amended to require

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

5 an opportunity for such a hearing, the Secretary de6 termines that inadequate grounds exist to support

7 the actions required by the order, the Secretary shall

8 vacate the order.

9 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE10 CALL.—

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

12 an informal hearing under paragraph (1), the

13 Secretary determines that the order should be

14 amended to include a recall of the tobacco prod15 uct with respect to which the order was issued,

16 the Secretary shall, except as provided in sub17 paragraph (B), amend the order to require a

18 recall. The Secretary shall specify a timetable in

19 which the tobacco product recall will occur and

20 shall require periodic reports to the Secretary

21 describing the progress of the recall.

22 ‘‘(B) An amended order under subpara23 graph (A)—

24 ‘‘(i) shall not include recall of a to25 bacco product from individuals; and
45

•S 2566 IS

1 ‘‘(ii) shall provide for notice to per2 sons subject to the risks associated with

3 the use of such tobacco product.

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

5 the Secretary may use the assistance of retail6 ers and other persons who distributed such to7 bacco product. If a significant number of such

8 persons cannot be identified, the Secretary shall

9 notify such persons under section 705(b).

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

11 provided by this subsection shall be in addition to

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

13 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD14 UCTS.

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

16 product manufacturer or importer of a tobacco product

17 shall establish and maintain such records, make such re18 ports, and provide such information, as the Secretary may

19 by regulation reasonably require to assure that such to20 bacco product is not adulterated or misbranded and to

21 otherwise protect public health. Regulations prescribed

22 under the preceding sentence—

23 ‘‘(1) may require a tobacco product manufac24 turer or importer to report to the Secretary when25 ever the manufacturer or importer receives or other-
46

•S 2566 IS

1 wise becomes aware of information that reasonably

2 suggests that one of its marketed tobacco products

3 may have caused or contributed to a serious unex4 pected adverse experience associated with the use of

5 the product or any significant increase in the fre6 quency of a serious, expected adverse product experi7 ence;

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

9 adverse tobacco product experiences as determined

10 by the Secretary to be necessary to be reported;

11 ‘‘(3) shall not impose requirements unduly bur12 densome to a tobacco product manufacturer or im13 porter, taking into account the cost of complying

14 with such requirements and the need for the protec15 tion of the public health and the implementation of

16 this chapter;

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

18 requests for reports or information, shall require

19 that each request made under such regulations for

20 submission of a report or information to the Sec21 retary state the reason or purpose for such request

22 and identify to the fullest extent practicable such re23 port or information;

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

25 information to the Secretary, shall state the reason
47

•S 2566 IS

1 or purpose for the submission of such report or in2 formation and identify to the fullest extent prac3 ticable such report or information; and

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

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

6 information required under this subsection unless re7 quired for the medical welfare of an individual, to

8 determine risks to public health of a tobacco prod9 uct, or to verify a record, report, or information sub10 mitted under this chapter.

11 In prescribing regulations under this subsection, the Sec12 retary shall have due regard for the professional ethics of

13 the medical profession and the interests of patients. The

14 prohibitions of paragraph (6) of this subsection continue

15 to apply to records, reports, and information concerning

16 any individual who has been a patient, irrespective of

17 whether or when he ceases to be a patient.

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

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

20 Secretary shall by regulation require a tobacco prod21 uct manufacturer or importer of a tobacco product

22 to report promptly to the Secretary any corrective

23 action taken or removal from the market of a to24 bacco product undertaken by such manufacturer or
48

•S 2566 IS

1 importer if the removal or correction was

2 undertaken—

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

4 the tobacco product; or

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

6 caused by the tobacco product which may

7 present a risk to health.

8 A tobacco product manufacturer or importer of a tobacco

9 product who undertakes a corrective action or removal

10 from the market of a tobacco product which is not re11 quired to be reported under this subsection shall keep a

12 record of such correction or removal.

13 ‘‘(2) No report of the corrective action or re14 moval of a tobacco product may be required under

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

16 removal is required and has been submitted under

17 subsection (a) of this section.

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

19 PRODUCTS.

20 ‘‘(a) IN GENERAL.—

21 ‘‘(1) PREMARKET APPROVAL REQUIRED.—Ap22 proval under this section of an application for pre23 market approval for any tobacco product, other than

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

25 commercially marketed (other than for test mar-
49

•S 2566 IS

1 keting) in the United States as of the date of this

2 Act’s enactment, is required unless the manufacturer

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

4 Secretary has issued an order within 90 days under

5 section 905(j) that the tobacco product is substan6 tially equivalent to a tobacco product commercially

7 marketed (other than for test marketing) in the

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

9 that is in compliance with the requirements of this

10 Act.

11 ‘‘(2) SUBSTANTIALLY EQUIVALENT DEFINED.—

12 ‘‘(A) For purposes of this section and sec13 tion 905(j), the term ‘substantially equivalent’

14 or ‘substantial equivalence’ mean, with respect

15 to the tobacco product being compared to the

16 predicate tobacco product, that the Secretary by

17 order has found that the tobacco 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-
50

•S 2566 IS

1 cause the product does not raise different

2 questions of public health.

3 ‘‘(B) For purposes of subparagraph (A),

4 the term ‘characteristics’ means the materials,

5 ingredients, design, composition, heating source,

6 or other features of a tobacco product.

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

8 to be substantially equivalent to a predicate to9 bacco product that has been removed from the

10 market at the initiative of the Secretary or that

11 has been determined by a judicial order to be

12 misbranded or adulterated.

13 ‘‘(3) HEALTH INFORMATION.—

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

15 905(j) respecting a tobacco product, the person

16 required to file a premarket notification under

17 such section shall provide an adequate summary

18 of any health information related to the tobacco

19 product or state that such information will be

20 made available upon request by any person.

21 ‘‘(B) Any summary under subparagraph

22 (A) respecting a tobacco product shall contain

23 detailed information regarding data concerning

24 adverse health effects and shall be made avail25 able to the public by the Secretary within 30
51

•S 2566 IS

1 days of the issuance of a determination that

2 such tobacco product is substantially equivalent

3 to another tobacco product. The communication

4 that such product is a reduced risk product

5 may comply with requirements prescribed by

6 the Secretary relating to such communication,

7 and the Secretary may require prior approval of

8 the communication.

9 ‘‘(b) APPLICATION.—

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

11 approval shall contain—

12 ‘‘(A) full reports of all information, pub13 lished or known to or which should reasonably

14 be known to the applicant, concerning investiga15 tions which have been made to show the health

16 risks of such tobacco product and whether such

17 tobacco product presents less risk than other

18 tobacco products;

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

20 ingredients, and properties, and of the principle

21 or principles of operation, of such tobacco prod22 uct;

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

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

25 manufacture, processing, and, when relevant,
52

•S 2566 IS

1 packing and installation of, such tobacco prod2 uct;

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

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

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

9 adequate information to justify any deviation

10 from such standard;

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

12 and of components thereof as the Secretary

13 may reasonably require;

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

15 be used for such tobacco product; and

16 ‘‘(G) such other information relevant to

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

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

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

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

24 ‘‘(B) shall, upon the request of an appli25 cant,
53

•S 2566 IS

1 refer such application to an advisory committee and

2 for submission (within such period as the Secretary

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

5 all underlying data and the reasons or basis for the

6 recommendation.

7 ‘‘(c) ACTION ON APPLICATION.—

8 ‘‘(1) DEADLINE.—

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

10 event later than 180 days after the receipt of

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

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

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

17 the grounds for denying approval specified

18 in paragraph (2) of this subsection applies;

19 or

20 ‘‘(ii) deny approval of the application

21 if the Secretary finds (and sets forth the

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

24 grounds for denial specified in paragraph

25 (2) of this subsection apply.
54

•S 2566 IS

1 ‘‘(B) An order approving an application for

2 a tobacco product may require as a condition to

3 such approval that the sale and distribution of

4 the tobacco product be restricted but only to

5 the extent that the sale and distribution of a

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

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

9 shall deny approval of an application for a tobacco

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

12 and any other information before the Secretary with

13 respect to such tobacco product, the Secretary finds

14 that—

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

17 would pose no greater risk to the public health

18 than currently marketed tobacco products;

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

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

22 not conform to the requirements of section

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

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

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

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

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

11 application shall, insofar as the Secretary determines

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

14 place such application in approvable form (which

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

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

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

20 tobacco product is appropriate for the protection of

21 the public health shall be determined with respect to

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

23 including users and non-users of the tobacco prod24 uct, and taking into account—
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•S 2566 IS

1 ‘‘(A) the increased or decreased likelihood

2 that existing users of tobacco products will stop

3 using such products; and

4 ‘‘(B) the increased or decreased likelihood

5 that those who do not use tobacco products will

6 start using such products.

7 ‘‘(5) BASIS FOR ACTION.—

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

9 whether permitting a tobacco product to be

10 marketed would be appropriate for the protec11 tion of the public health shall, when appro12 priate, be determined on the basis of well-con13 trolled investigations, which may include one or

14 more clinical investigations by experts qualified

15 by training and experience to evaluate the to16 bacco product.

17 ‘‘(B) If the Secretary determines that

18 there exists valid scientific evidence (other than

19 evidence derived from investigations described

20 in subparagraph (A)) which is sufficient to

21 evaluate the tobacco product the Secretary may

22 authorize that the determination for purposes

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

24 such evidence.

25 ‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.—
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1 ‘‘(1) IN GENERAL.—The Secretary shall, upon

2 obtaining, where appropriate, advice on scientific

3 matters from an advisory committee, and after due

4 notice and opportunity for informal hearing to the

5 holder of an approved application for a tobacco

6 product, issue an order withdrawing approval of the

7 application if the Secretary finds—

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

9 tobacco product poses greater risks to the pub10 lic health than other available products;

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

12 accompanied by an untrue statement of a mate13 rial fact;

14 ‘‘(C) that the applicant—

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

16 for maintaining records, or has repeatedly

17 or deliberately failed to maintain records

18 or to make reports, required by an applica19 ble regulation under section 909;

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

21 or copying or verification of, such records

22 as required by section 704; or

23 ‘‘(iii) has not complied with the re24 quirements of section 905;
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•S 2566 IS

1 ‘‘(D) on the basis of new information be2 fore the Secretary with respect to such tobacco

3 product, evaluated together with the evidence

4 before the Secretary when the application was

5 approved, that the methods used in, or the fa6 cilities and controls used for, the manufacture,

7 processing, packing, or installation of such to8 bacco product do not conform with the require9 ments of section 906(e) and were not brought

10 into conformity with such requirements within a

11 reasonable time after receipt of written notice

12 from the Secretary of nonconformity;

13 ‘‘(E) on the basis of new information be14 fore the Secretary, evaluated together with the

15 evidence before the Secretary when the applica16 tion was approved, that the labeling of such to17 bacco product, based on a fair evaluation of all

18 material facts, is false or misleading in any par19 ticular and was not corrected within a reason20 able time after receipt of written notice from

21 the Secretary of such fact; or

22 ‘‘(F) on the basis of new information be23 fore the Secretary, evaluated together with the

24 evidence before the Secretary when the applica25 tion was approved, that such tobacco product is
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•S 2566 IS

1 not shown to conform in all respects to a per2 formance standard which is in effect under sec3 tion 907, compliance with which was a condi4 tion to approval of the application, and that

5 there is a lack of adequate information to jus6 tify the deviation from such standard.

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

8 subject to an order issued under paragraph (1) with9 drawing approval of the application may, by petition

10 filed on or before the thirtieth day after the date

11 upon which he receives notice of such withdrawal,

12 obtain review thereof in accordance with subsection

13 (e) of this section.

14 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro15 viding an opportunity for an informal hearing, the

16 Secretary determines there is reasonable probability

17 that the continuation of distribution of a tobacco

18 product under an approved application would cause

19 serious, adverse health consequences or death, that

20 is greater than ordinarily caused by tobacco prod21 ucts on the market, the Secretary shall by order

22 temporarily suspend the approval of the application

23 approved under this section. If the Secretary issues

24 such an order, the Secretary shall proceed expedi-
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•S 2566 IS

1 tiously under paragraph (1) to withdraw such appli2 cation.

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

4 Secretary under this section shall be served—

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

6 department designated by the Secretary; or

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

8 certified mail addressed to the applicant at the ap9 plicant’s last known address in the records of the

10 Secretary.

11 ‘‘SEC. 911. JUDICIAL REVIEW.

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

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

14 section 907 establishing, amending, or revoking a

15 performance standard for a tobacco product; or

16 ‘‘(2) a denial of an application for approval

17 under section 910(c),

18 any person adversely affected by such regulation or order

19 may file a petition with the United States Court of Ap20 peals for the District of Columbia or for the circuit where21 in such person resides or has his principal place of busi22 ness for judicial review of such regulation or order. A copy

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

24 court to the Secretary or other officer designated by the

25 Secretary for that purpose. The Secretary shall file in the
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1 court the record of the proceedings on which the Secretary

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

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

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

5 purposes of this section, the term ‘record’ means all no6 tices and other matter published in the Federal Register

7 with respect to the regulation or order reviewed, all infor8 mation submitted to the Secretary with respect to such

9 regulation or order, proceedings of any panel or advisory

10 committee with respect to such regulation or order, any

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

12 any other information identified by the Secretary, in the

13 administrative proceeding held with respect to such regu14 lation or order, as being relevant to such regulation or

15 order.

16 ‘‘(b) COURT MAY ORDER SECRETARY TO MAKE AD17 DITIONAL FINDINGS.—If the petitioner applies to the

18 court for leave to adduce additional data, views, or argu19 ments respecting the regulation or order being reviewed

20 and shows to the satisfaction of the court that such addi21 tional data, views, or arguments are material and that

22 there were reasonable grounds for the petitioner’s failure

23 to adduce such data, views, or arguments in the pro24 ceedings before the Secretary, the court may order the

25 Secretary to provide additional opportunity for the oral
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•S 2566 IS

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

2 submissions. The Secretary may modify the Secretary’s

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

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

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

6 recommendation, if any, for the modification or setting

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

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

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

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

11 review of a regulation or order, the court shall have juris12 diction to review the regulation or order in accordance

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

14 appropriate relief, including interim relief, as provided in

15 such chapter. A regulation or order described in paragraph

16 (1) or (2) of subsection (a) of this section shall not be

17 affirmed if it is found to be unsupported by substantial

18 evidence on the record taken as a whole.

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

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

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

22 Supreme Court of the United States upon certiorari or

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

24 United States Code.
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1 ‘‘(e) OTHER REMEDIES.—The remedies provided for

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

3 any other remedies provided by law.

4 ‘‘(f) REGULATIONS AND ORDERS MUST RECITE

5 BASIS IN RECORD.—To facilitate judicial review under

6 this section or under any other provision of law of a regu7 lation or order issued under section 906, 907, 908, 909,

8 910, or 913, each such regulation or order shall contain

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

10 in the record of the proceedings held in connection with

11 its issuance, for its issuance.

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

13 ‘‘(a) REQUIREMENTS.—

14 ‘‘(1) IN GENERAL.—For purposes of this sec15 tion, the term ‘reduced risk tobacco product’ means

16 a tobacco product designated by the Secretary under

17 paragraph (2).

18 ‘‘(2) DESIGNATION.—

19 ‘‘(A) IN GENERAL.—A product may be

20 designated by the Secretary as a reduced risk

21 tobacco product if the Secretary finds that the

22 product will significantly reduce harm to indi23 viduals caused by a tobacco product and is oth24 erwise appropriate to protect public health,

25 based on an application submitted by the manu-
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•S 2566 IS

1 facturer of the product (or other responsible

2 person) that—

3 ‘‘(i) demonstrates through testing on

4 animals and short-term human testing that

5 use of such product results in ingestion or

6 inhalation of a substantially lower yield of

7 toxic substances than use of conventional

8 tobacco products in the same category as

9 the proposed reduced risk product; and

10 ‘‘(ii) if required by the Secretary, in11 cludes studies of the long-term health ef12 fects of the product.

13 If such studies are required, the manufacturer

14 may consult with the Secretary regarding proto15 cols for conducting the studies.

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

17 finding under subparagraph (A), the Secretary

18 shall take into account—

19 ‘‘(i) the risks and benefits to the pop20 ulation as a whole, including both users of

21 tobacco products and non-users of tobacco

22 products;

23 ‘‘(ii) the increased or decreased likeli24 hood that existing users of tobacco prod-
65

•S 2566 IS

1 ucts will stop using such products includ2 ing reduced risk tobacco products;

3 ‘‘(iii) the increased or decreased likeli4 hood that those who do not use tobacco

5 products will start to use such products,

6 including reduced risk tobacco products;

7 and

8 ‘‘(iv) the risks and benefits to con9 sumers from the use of a reduced risk to10 bacco product as compared to the use of

11 products approved under chapter V to re12 duce exposure to tobacco.

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

14 product may be marketed and labeled as a reduced

15 risk tobacco product if it—

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

17 tobacco product by the Secretary under para18 graph (2);

19 ‘‘(B) bears a label prescribed by the Sec20 retary concerning the product’s contribution to

21 reducing harm to health; and

22 ‘‘(C) complies with requirements prescribed

23 by the Secretary relating to marketing and ad24 vertising of the product, and other provisions of

25 this chapter as prescribed by the Secretary, al-
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•S 2566 IS

1 though in no event shall such requirements pro2 hibit the communication that such product is a

3 reduced risk product. The communication that

4 such product is a reduced risk product may

5 comply with requirements prescribed by the

6 Secretary relating to such communication, and

7 the Secretary may require prior approval of the

8 communication.

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

10 after the date on which a tobacco product is designated

11 as a reduced risk tobacco product under this section the

12 Secretary may, after providing an opportunity for an in13 formal hearing, revoke such designation if the Secretary

14 determines, based on information not available at the time

15 of the designation, that—

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

17 is no longer valid; or

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

19 of subsection (a)(3).

20 ‘‘(c) LIMITATION.—A tobacco product that is des21 ignated as a reduced risk tobacco product that is in com22 pliance with subsection (a) shall not be regulated as a

23 drug or device.

24 ‘‘(d) DEVELOPMENT OF REDUCED RISK TOBACCO

25 PRODUCT TECHNOLOGY.—A tobacco product manufac-
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•S 2566 IS

1 turer shall provide written notice to the Secretary upon

2 the development or acquisition by the manufacturer of any

3 technology that would reduce the risk of a tobacco product

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

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

6 under subsection (a).

7 ‘‘(e) POSTMARKET SURVEILLANCE.—

8 ‘‘(1) DISCRETIONARY SURVEILLANCE.—The

9 Secretary may require a tobacco product manufac10 turer to conduct postmarket surveillance for reduced

11 risk a tobacco product of the manufacturer if the

12 Secretary determines that postmarket surveillance of

13 the tobacco product is necessary to protect the pub14 lic health or is necessary to provide information re15 garding the health risks and other safety issues in16 volving the tobacco product.

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

18 product manufacturer required to conduct a surveil19 lance of a reduced risk tobacco product under para20 graph (1) shall, within 30 days after receiving notice

21 that the manufacturer is required to conduct such

22 surveillance, submit, for the approval of the Sec23 retary, a protocol for the required surveillance. The

24 Secretary, within 60 days of the receipt of such pro25 tocol, shall determine if the principal investigator
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•S 2566 IS

1 proposed to be used in the surveillance has sufficient

2 qualifications and experience to conduct such sur3 veillance and if such protocol will result in collection

4 of useful data or other information necessary to pro5 tect the public health. The Secretary may not ap6 prove such a protocol until it has been reviewed by

7 an appropriately qualified scientific and technical re8 view committee established by the Secretary.

9 ‘‘SEC. 913. PRESERVATION OF STATE AND LOCAL AUTHOR10 ITY.

11 ‘‘(a) ADDITIONAL REQUIREMENTS.—

12 ‘‘(1) IN GENERAL.—Except as provided in para13 graph (2), nothing in this Act shall be construed as

14 prohibiting a State or political subdivision thereof

15 from adopting or enforcing a requirement applicable

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

17 stringent than, requirements established under this

18 chapter.

19 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

20 LOCAL REQUIREMENTS.—

21 ‘‘(A) Except as provided in subparagraph

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

23 may establish or continue in effect with respect

24 to a tobacco product any requirement which is

25 different from, or in addition to, any require-
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•S 2566 IS

1 ment applicable under the provisions of this

2 chapter relating to performance standards, pre3 market approval, adulteration, misbranding,

4 registration, labeling, good manufacturing

5 standards, or reduced risk products.

6 ‘‘(B) Subparagraph (A) does not apply to

7 requirements relating to the sale, use, or dis8 tribution of a tobacco product including require9 ments related to the access to, and the adver10 tising and promotion of, a tobacco product.

11 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

12 LIABILITY.—No provision of this chapter relating to a to13 bacco product shall be construed to modify or otherwise

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

15 product liability law of any State.

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

17 ‘‘The Secretary shall issue regulations to require that

18 retail establishments for which the predominant business

19 is the sale of tobacco products comply with any advertising

20 restrictions applicable to retail establishments accessible

21 to individuals under the age of 18.’’.

22 SEC. 5. REGULATORY RECORD.

23 Notwithstanding the provisions of subchapter II of

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

25 regulations under this chapter, the record developed and
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•S 2566 IS

1 utilized by the Secretary for the purposes of promulgating

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

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

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

5 preamble to the 1996 Food and Drug Administration To6 bacco Rule (including public comments, Food and Drug

7 Administration documents, and any other information

8 generated or compiled for purposes of promulgating such

9 regulations), shall be deemed to have the same legal status

10 as if such record had been developed under a rulemaking

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

12 other respects, including with respect to the issue of

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

14 the procedural requirements of this chapter and the Ad15 ministration Procedure Act will apply.

16 SEC. 6. CONFORMING AND OTHER AMENDMENTS TO GEN17 ERAL PROVISIONS.

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

19 COSMETIC ACT.—Except as otherwise expressly provided,

20 whenever in this section an amendment is expressed in

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

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

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

24 301 et seq.).
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1 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is

2 amended—

3 (1) by inserting ‘‘tobacco product,’’ in sub4 section (a) after ‘‘device,’’;

5 (2) by inserting ‘‘tobacco product,’’ in sub6 section (b) after ‘‘device,’’;

7 (3) by inserting ‘‘tobacco product,’’ in sub8 section (c) after ‘‘device,’’;

9 (4) by striking ‘‘515(f), or 519’’ in subsection

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

11 (5) by inserting ‘‘tobacco product,’’ in sub12 section (g) after ‘‘device,’’;

13 (6) by inserting ‘‘tobacco product,’’ in sub14 section (h) after ‘‘device,’’;

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

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

17 908, 909, 910, or 912’’;

18 (8) by inserting ‘‘tobacco product,’’ in sub19 section (k) after ‘‘device,’’;

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

21 following:

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

23 510 or 905, the failure to provide any information re24 quired by section 510(j), 510(k), 905(i), or 905(j), or the
72

•S 2566 IS

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

2 or 905(J)(2).’’;

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

4 the following:

5 ‘‘(q)(1) The failure or refusal—

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

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

8 ‘‘(B) to furnish any notification or other mate9 rial or information required by or under section 519,

10 520(g), 904, 906(f), or 909; or

11 ‘‘(C) to comply with a requirement under sec12 tion 522.’’;

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

14 and inserting ‘‘device or tobacco product,’’;

15 (12) by inserting ‘‘or tobacco product’’ in sub16 section (r) after ‘‘device’’ each time that it appears;

17 and

18 (13) by adding at the end thereof the following:

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

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

21 303(f).’’.

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

23 is amended—

24 (1) by amending the caption to read as follows:
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•S 2566 IS

1 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR2 DERS.—’’;

3 (2) by inserting ‘‘or tobacco products’’ after

4 ‘‘devices’’ in paragraph (1)(A);

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

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

7 after paragraph (2) the following:

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

9 committed repeated violations of restrictions promul10 gated under section 906(d) at a particular retail out11 let then the Secretary may impose a no-tobacco-sale

12 order on that person prohibiting the sale of tobacco

13 products in that outlet. A no-tobacco-sale order may

14 be imposed with a civil penalty under paragraph

15 (1).’’;

16 (4) by striking ‘‘assessed’’ the first time it ap17 pears in subparagraph (A) of paragraph (4), as re18 designated, and inserting ‘‘assessed, or a no-tobacco19 sale order may be imposed,’’;

20 (5) by striking ‘‘penalty’’ in such subparagraph

21 and inserting ‘‘penalty, or upon whom a no-tobacco22 order is to be imposed,’’;

23 (6) by inserting after ‘‘penalty,’’ in subpara24 graph (B) of paragraph (4), as redesignated, the fol-
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•S 2566 IS

1 lowing: ‘‘or the period to be covered by a no-tobacco2 sale order,’’;

3 (7) by adding at the end of such subparagraph

4 the following: ‘‘A no-tobacco-sale order permanently

5 prohibiting an individual retail outlet from selling to6 bacco products shall include provisions that allow

7 the outlet, after a specified period of time, to request

8 that the Secretary compromise, modify, or terminate

9 the order.’’;

10 (8) by adding at the end of paragraph (4), as

11 redesignated, the following:

12 ‘‘(D) The Secretary may compromise, mod13 ify, or terminate, with or without conditions,

14 any no-tobacco-sale order.’’;

15 (9) by striking ‘‘(3)(A)’’ in paragraph (5), as

16 redesignated, and inserting ‘‘(4)(A)’’;

17 (10) by inserting ‘‘or the imposition of a no-to18 bacco-sale order’’ after ‘‘penalty’’ the first 2 places

19 it appears in such paragraph;

20 (11) by striking ‘‘issued.’’ in such paragraph

21 and inserting ‘‘issued, or on which the no-tobacco22 sale order was imposed, as the case may be.’’; and

23 (12) by striking ‘‘paragraph (4)’’ each place it

24 appears in paragraph (6), as redesignated, and in25 serting ‘‘paragraph (5)’’.
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1 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is

2 amended—

3 (1) by striking ‘‘and’’ before ‘‘(D)’’ in sub4 section (a)(2);

5 (2) by striking ‘‘device.’’ in subsection (a)(2)

6 and inserting a comma and ‘‘(E) Any adulterated or

7 misbranded tobacco product.’’;

8 (3) by inserting ‘‘tobacco product,’’ in sub9 section (d)(1) after ‘‘device,’’;

10 (4) by inserting ‘‘or tobacco product’’ in sub11 section (g)(1) after ‘‘device’’ each place it appears;

12 and

13 (5) by inserting ‘‘or tobacco product’’ in sub14 section (g)(2)(A) after ‘‘device’’ each place it ap15 pears.

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

17 372(a)) is amended—

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

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

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

21 the Secretary shall contract with the States in accordance

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

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

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

25 amended—
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1 (1) by inserting ‘‘tobacco product,’’ after ‘‘de2 vice,’’ each place it appears; and

3 (2) by inserting ‘‘tobacco products,’’ after ‘‘de4 vices,’’ each place it appears.

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

6 amended—

7 (1) by inserting ‘‘tobacco products,’’ in sub8 section (a)(1)(A) after ‘‘devices,’’ each place it ap9 pears;

10 (2) by inserting ‘‘or tobacco products’’ in sub11 section (a)(1)(B) after ‘‘restricted devices’’ each

12 place it appears; and

13 (3) by inserting ‘‘tobacco product,’’ in sub14 section (b) after ‘‘device,’’.

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

16 375(b)) is amended by inserting ‘‘tobacco products,’’ after

17 ‘‘devices,’’.

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

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

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

21 amended—

22 (1) by inserting ‘‘tobacco products,’’ after ‘‘de23 vices,’’ in subsection (a) the first time it appears;

24 (2) by inserting ‘‘or subsection (j) of section

25 905’’ in subsection (a) after ‘‘section 510’’; and
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1 (3) by striking ‘‘drugs or devices’’ each time it

2 appears in subsection (a) and inserting ‘‘drugs, de3 vices, or tobacco products’’.

4 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re5 designated by section 101(a)) is amended—

6 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and

7 (2) inserting a comma and ‘‘and tobacco prod8 ucts’’ after ‘‘devices’’.

9 (l) EFFECTIVE DATE FOR NO-TOBACCO-SALE

10 ORDER AMENDMENTS.—The amendments made by sub11 section (c), other than the amendment made by paragraph

12 (2) thereof, shall take effect only upon the promulgation

13 of final regulations by the Secretary—

14 (1) defining the term ‘‘repeated violation’’, as

15 used in section 303(f) of the Federal Food, Drug,

16 and Cosmetic Act (21 U.S.C. 333(f)) as amended by

17 subsection (c), by identifying the number of viola18 tions of particular requirements over a specified pe19 riod of time that constitute a repeated violation;

20 (2) providing for notice to the retailer of each

21 violation at a particular retail outlet;

22 (3) providing that a person may not be charged

23 with repeated violations at a particular retail outlet

24 unless the Secretary has provided notice of previous

25 violations at that outlet;
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1 (4) establishing a period of time during which,

2 if there are no violations by a particular retail out3 let, that outlet will not considered to have been the

4 site of repeated violations when the next violation oc5 curs; and

6 (5) providing that good faith reliance on false

7 identification does not constitute a violation of any

8 minimum age requirement for the sale of tobacco

9 products.

10 SEC. 7. CIGARETTE LABEL AND ADVERTISING WARNINGS.

11 Section 4 of the Federal Cigarette Labeling and Ad12 vertising Act (15 U.S.C. 1333) is amended to read as fol13 lows:

14 ‘‘SEC. 4. LABELING.

15 ‘‘(a) LABEL REQUIREMENTS.—

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

17 person to manufacture, package, or import for sale

18 or distribution within the United States any ciga19 rettes the package of which fails to bear, in accord20 ance with the requirements of this section, one of

21 the following labels:

22 ‘‘WARNING: Cigarettes are addictive’’

23 ‘‘WARNING: Tobacco smoke can harm your chil24 dren’’

25 ‘‘WARNING: Cigarettes cause fatal lung disease’’
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1 ‘‘WARNING: Cigarettes cause cancer’’

2 ‘‘WARNING: Cigarettes cause strokes and heart

3 disease’’

4 ‘‘WARNING: Smoking during pregnancy can harm

5 your baby’’

6 ‘‘WARNING: Smoking can kill you’’

7 ‘‘WARNING: Tobacco smoke causes fatal lung dis8 ease in non-smokers’’

9 ‘‘WARNING: Quitting smoking now greatly reduces

10 serious risks to your health’’

11 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.—

12 ‘‘(A) IN GENERAL.—Each label statement

13 required by paragraph (1) shall be located in

14 the upper portion of the front and rear panels

15 of the package, directly on the package under16 neath the cellophane or other clear wrapping.

17 Except as provided in subparagraph (B), each

18 label statement shall comprise at least the top

19 25 percent of the front and rear panels of the

20 package. The word ‘‘WARNING’’ shall appear

21 in capital letters and all text shall be in con22 spicuous and legible 17-point type, unless the

23 text of the label statement would occupy more

24 than 70 percent of such area, in which case the

25 text may be in a smaller conspicuous and leg-
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1 ible type size, provided that at least 60 percent

2 of such area is occupied by required text. The

3 text shall be black on a white background, or

4 white on a black background, in a manner that

5 contrasts, by typography, layout, or color, with

6 all other printed material on the package, in an

7 alternating fashion under the plan submitted

8 under subsection (b)(4).

9 ‘‘(B) FLIP-TOP BOXES.—For any cigarette

10 brand package manufactured or distributed be11 fore January 1, 2000, which employs a flip-top

12 style (if such packaging was used for that

13 brand in commerce prior to June 21, 1997), the

14 label statement required by paragraph (1) shall

15 be located on the flip-top area of the package,

16 even if such area is less than 25 percent of the

17 area of the front panel. Except as provided in

18 this paragraph, the provisions of this subsection

19 shall apply to such packages.

20 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU21 TION.—The provisions of this subsection do not

22 apply to a tobacco product manufacturer or dis23 tributor of cigarettes which does not manufacture,

24 package, or import cigarettes for sale or distribution

25 within the United States.
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1 ‘‘(b) ADVERTISING REQUIREMENTS.—

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

3 tobacco product manufacturer, importer, distributor,

4 or retailer of cigarettes to advertise or cause to be

5 advertised within the United States any cigarette

6 unless its advertising bears, in accordance with the

7 requirements of this section, one of the labels speci8 fied in subsection (a) of this section.

9 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement

10 required by subsection (a) of this section in cigarette

11 advertising shall comply with the standards set forth

12 in this paragraph. For press and poster advertise13 ments, each such statement and (where applicable)

14 any required statement relating to tar, nicotine, or

15 other constituent yield shall comprise at least 20

16 percent of the area of the advertisement and shall

17 appear in a conspicuous and prominent format and

18 location at the top of each advertisement within the

19 trim area. The Secretary may revise the required

20 type sizes in such area in such manner as the Sec21 retary determines appropriate. The word ‘‘WARN22 ING’’ shall appear in capital letters, and each label

23 statement shall appear in conspicuous and legible

24 type. The text of the label statement shall be black

25 if the background is white and white if the back-
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1 ground is black, under the plan submitted under

2 paragraph (4) of this subsection. The label state3 ments shall be enclosed by a rectangular border that

4 is the same color as the letters of the statements

5 and that is the width of the first downstroke of the

6 capital ‘‘W’’ of the word ‘‘WARNING’’ in the label

7 statements. The text of such label statements shall

8 be in a typeface pro rata to the following require9 ments: 45-point type for a whole-page broadsheet

10 newspaper advertisement; 39-point type for a half11 page broadsheet newspaper advertisement; 39-point

12 type for a whole-page tabloid newspaper advertise13 ment; 27-point type for a half-page tabloid news14 paper advertisement; 31.5-point type for a double

15 page spread magazine or whole-page magazine ad16 vertisement; 22.5-point type for a 28 centimeter by

17 3 column advertisement; and 15-point type for a 20

18 centimeter by 2 column advertisement. The label

19 statements shall be in English, except that in the

20 case of—

21 ‘‘(A) an advertisement that appears in a

22 newspaper, magazine, periodical, or other publi23 cation that is not in English, the statements

24 shall appear in the predominant language of the

25 publication; and
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1 ‘‘(B) in the case of any other advertise2 ment that is not in English, the statements

3 shall appear in the same language as that prin4 cipally used in the advertisement.

5 ‘‘(3) ADJUSTMENT BY SECRETARY.—The Sec6 retary may, through a rulemaking under section 553

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

8 type sizes for the label statements required by this

9 section or the text, format, and type sizes of any re10 quired tar, nicotine yield, or other constituent disclo11 sures, or to establish the text, format, and type sizes

12 for any other disclosures required under the Federal

13 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et.

14 seq.). The text of any such label statements or dis15 closures shall be required to appear only within the

16 20 percent area of cigarette advertisements provided

17 by paragraph (2) of this subsection. The Secretary

18 shall promulgate regulations which provide for ad19 justments in the format and type sizes of any text

20 required to appear in such area to ensure that the

21 total text required to appear by law will fit within

22 such area.

23 ‘‘(4) MARKETING REQUIREMENTS.—

24 ‘‘(A) The label statements specified in sub25 section (a)(1) shall be randomly displayed in
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1 each 12-month period, in as equal a number of

2 times as is possible on each brand of the prod3 uct and be randomly distributed in all areas of

4 the United States in which the product is mar5 keted in accordance with a plan submitted by

6 the tobacco product manufacturer, importer,

7 distributor, or retailer and approved by the Sec8 retary.

9 ‘‘(B) The label statements specified in sub10 section (a)(1) shall be rotated quarterly in al11 ternating sequence in advertisements for each

12 brand of cigarettes in accordance with a plan

13 submitted by the tobacco product manufacturer,

14 importer, distributor, or retailer to, and ap15 proved by, the Secretary.

16 ‘‘(C) The Secretary shall review each plan

17 submitted under subparagraph (B) and approve

18 it if the plan—

19 ‘‘(i) will provide for the equal distribu20 tion and display on packaging and the ro21 tation required in advertising under this

22 subsection; and

23 ‘‘(ii) assures that all of the labels re24 quired under this section will be displayed

25 by the tobacco product manufacturer, im-
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1 porter, distributor, or retailer at the same

2 time.’’.

3 SEC. 8. AUTHORITY TO REVISE CIGARETTE WARNING

4 LABEL STATEMENTS.

5 Section 4 of the Federal Cigarette Labeling and Ad6 vertising Act (15 U.S.C. 1333), as amended by section 4,

7 is further amended by adding at the end the following:

8 ‘‘(c) CHANGE IN REQUIRED STATEMENTS.—The Sec9 retary may, by a rulemaking conducted under section 553

10 of title 5, United States Code, adjust the format, type size,

11 and text of any of the warning label statements required

12 by subsection (a) of this section subject to the limitation

13 on proportional size of the warning contained in sub14 sections (a)(2) and (b)(2), or establish the format, type

15 size, and text of any other disclosures required under the

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301

17 et seq.), if the Secretary finds that such a change would

18 promote greater public understanding of the risks associ19 ated with the use of smokeless tobacco products.’’.

20 SEC. 9. SMOKELESS TOBACCO LABELS AND ADVERTISING

21 WARNINGS.

22 Section 3 of the Comprehensive Smokeless Tobacco

23 Health Education Act of 1986 (15 U.S.C. 4402) is amend24 ed to read as follows:
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1 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING.

2 ‘‘(a) GENERAL RULE.—

3 ‘‘(1) It shall be unlawful for any person to man4 ufacture, package, or import for sale or distribution

5 within the United States any smokeless tobacco

6 product unless the product package bears, in accord7 ance with the requirements of this Act, one of the

8 following labels:

9 ‘‘WARNING: This product can cause mouth cancer’’

10 ‘‘WARNING: This product can cause gum disease

11 and tooth loss’’

12 ‘‘WARNING: This product is not a safe alternative

13 to cigarettes’’

14 ‘‘WARNING: Smokeless tobacco is addictive’’

15 ‘‘(2) Each label statement required by para16 graph (1) shall be—

17 ‘‘(A) located on the 2 principal display

18 panels of the package, and each label statement

19 shall comprise at least 25 percent of each such

20 display panel; and

21 ‘‘(B) in 17-point conspicuous and legible

22 type and in black text on a white background,

23 or white text on a black background, in a man24 ner that contrasts by typography, layout, or

25 color, with all other printed material on the

26 package, in an alternating fashion under the
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1 plan submitted under subsection (b)(3), except

2 that if the text of a label statement would oc3 cupy more than 70 percent of the area specified

4 by subparagraph (A), such text may appear in

5 a smaller type size, so long as at least 60 per6 cent of such warning area is occupied by the

7 label statement.

8 ‘‘(3) The label statements required by para9 graph (1) shall be introduced by each tobacco prod10 uct manufacturer, packager, importer, distributor, or

11 retailer of smokeless tobacco products concurrently

12 into the distribution chain of such products.

13 ‘‘(4) The provisions of this subsection do not

14 apply to a tobacco product manufacturer or dis15 tributor of any smokeless tobacco product that does

16 not manufacture, package, or import smokeless to17 bacco products for sale or distribution within the

18 United States.

19 ‘‘(b) REQUIRED LABELS.—

20 ‘‘(1) It shall be unlawful for any tobacco prod21 uct manufacturer, packager, importer, distributor, or

22 retailer of smokeless tobacco products to advertise or

23 cause to be advertised within the United States any

24 smokeless tobacco product unless its advertising
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1 bears, in accordance with the requirements of this

2 section, one of the labels specified in subsection (a).

3 ‘‘(2) Each label statement required by sub4 section (a) in smokeless tobacco advertising shall

5 comply with the standards set forth in this para6 graph. For press and poster advertisements, each

7 such statement and (where applicable) any required

8 statement relating to tar, nicotine, or other con9 stituent yield shall—

10 ‘‘(A) comprise at least 20 percent of the

11 area of the advertisement, and the warning area

12 shall be delineated by a dividing line of con13 trasting color from the advertisement; and

14 ‘‘(B) the word ‘‘WARNING’’ shall appear

15 in capital letters and each label statement shall

16 appear in conspicuous and legible type. The text

17 of the label statement shall be black on a white

18 background, or white on a black background, in

19 an alternating fashion under the plan submitted

20 under paragraph (3).

21 ‘‘(3)(A) The label statements specified in sub22 section (a)(1) shall be randomly displayed in each

23 12-month period, in as equal a number of times as

24 is possible on each brand of the product and be ran25 domly distributed in all areas of the United States
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1 in which the product is marketed in accordance with

2 a plan submitted by the tobacco product manufac3 turer, importer, distributor, or retailer and approved

4 by the Secretary.

5 ‘‘(B) The label statements specified in sub6 section (a)(1) shall be rotated quarterly in alter7 nating sequence in advertisements for each brand of

8 smokeless tobacco product in accordance with a plan

9 submitted by the tobacco product manufacturer, im10 porter, distributor, or retailer to, and approved by,

11 the Secretary.

12 ‘‘(C) The Secretary shall review each plan sub13 mitted under subparagraph (B) and approve it if the

14 plan—

15 ‘‘(i) will provide for the equal distribution

16 and display on packaging and the rotation re17 quired in advertising under this subsection; and

18 ‘‘(ii) assures that all of the labels required

19 under this section will be displayed by the to20 bacco product manufacturer, importer, dis21 tributor, or retailer at the same time.

22 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is

23 unlawful to advertise smokeless tobacco on any medium

24 of electronic communications subject to the jurisdiction of

25 the Federal Communications Commission.’’.
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1 SEC. 10. AUTHORITY TO REVISE SMOKELESS TOBACCO

2 PRODUCT WARNING LABEL STATEMENTS.

3 Section 3 of the Comprehensive Smokeless Tobacco

4 Health Education Act of 1986 (15 U.S.C. 4402), as

5 amended by section 6, is further amended by adding at

6 the end the following:

7 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

8 STATEMENTS.—The Secretary may, by a rulemaking con9 ducted under section 553 of title 5, United States Code,

10 adjust the format, type size, and text of any of the warn11 ing label statements required by subsection (a) of this sec12 tion, subject to the limitations on proportional size of the

13 warning contained in paragraphs (2) and (3) of subsection

14 (a), or establish the format, type size, and text of any

15 other disclosures required under the Federal Food, Drug,

16 and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary

17 finds that such a change would promote greater public un18 derstanding of the risks associated with the use of smoke19 less tobacco products.’’.

20 SEC. 11. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT

21 DISCLOSURE TO THE PUBLIC.

22 Section 4(a) of the Federal Cigarette Labeling and

23 Advertising Act (15 U.S.C. 1333(a)), as amended by sec24 tion 4 of this title, is further amended by adding at the

25 end the following:
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1 ‘‘(4)(A) The Secretary shall, by a rulemaking

2 conducted under section 553 of title 5, United

3 States Code, determine (in the Secretary’s sole dis4 cretion) whether cigarette and other tobacco product

5 manufacturers shall be required to include in the

6 area of each cigarette advertisement specified by

7 subsection (b) of this section, or on the package

8 label, or both, the tar and nicotine yields of the ad9 vertised or packaged brand. Any such disclosure

10 shall be in accordance with the methodology estab11 lished under such regulations, shall conform to the

12 type size requirements of subsection (b) of this sec13 tion, and shall appear within the area specified in

14 subsection (b) of this section.

15 ‘‘(B) Any differences between the requirements

16 established by the Secretary under subparagraph (A)

17 and tar and nicotine yield reporting requirements es18 tablished by the Federal Trade Commission shall be

19 resolved by a memorandum of understanding be20 tween the Secretary and the Federal Trade Commis21 sion.

22 ‘‘(C) In addition to the disclosures required by

23 subparagraph (A) of this paragraph, the Secretary

24 may, under a rulemaking conducted under section

25 553 of title 5, United States Code, prescribe disclo-
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1 sure requirements regarding the level of any ciga2 rette or other tobacco product smoke constituent.

3 Any such disclosure may be required if the Secretary

4 determines that disclosure would be of benefit to the

5 public health, or otherwise would increase consumer

6 awareness of the health consequences of the use of

7 tobacco products, except that no such prescribed dis8 closure shall be required on the face of any cigarette

9 package or advertisement. Nothing in this section

10 shall prohibit the Secretary from requiring such pre11 scribed disclosure through a cigarette or other to12 bacco product package or advertisement insert, or by

13 any other means under the Federal Food, Drug, and

14 Cosmetic Act (21 U.S.C. 301 et seq.).’’.

15 SEC. 12. REGULATION REQUIREMENT.

16 (a) TESTING, REPORTING, AND DISCLOSURE.—Not

17 later than 24 months after the date of enactment of this

18 Act, the Secretary, through the Commissioner of the Food

19 and Drug Administration, shall promulgate regulations

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

21 U.S.C. 301 et seq.) that meet the requirements of sub22 section (b) of this section.

23 (b) CONTENTS OF RULES.—The rules promulgated

24 under subsection (a) shall require the testing, reporting,

25 and disclosure of tobacco product smoke constituents and
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1 ingredients that the Secretary determines should be dis2 closed to the public in order to protect the public health.

3 Such constituents shall include tar, nicotine, carbon mon4 oxide, and such other smoke constituents or ingredients

5 as the Secretary may determine to be appropriate. The

6 rule may require that tobacco product manufacturers,

7 packagers, or importers make such disclosures relating to

8 tar and nicotine through labels or advertising, and make

9 such disclosures regarding other smoke constituents or in10 gredients as the Secretary determines are necessary to

11 protect the public health.

12 (c) AUTHORITY.—The Food and Drug Administra13 tion shall have authority to conduct or to require the test14 ing, reporting, or disclosure of tobacco product smoke con15 stituents.

16 SEC. 13. FTC JURISDICTION NOT AFFECTED.

17 (a) IN GENERAL.—Except where expressly provided

18 in this Act, nothing in this Act shall be construed as lim19 iting or diminishing the authority of the Federal Trade

20 Commission to enforce the laws under its jurisdiction with

21 respect to the advertising, sale, or distribution of tobacco

22 products.

23 (b) ENFORCEMENT BY FTC.—Any advertising that

24 violates this Act is an unfair or deceptive act or practice

25 under section 5(a) of the Federal Trade Commission Act
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1 (15 U.S.C. 45(a)) and shall be considered a violation of

2 a rule promulgated under section 18 of that Act (15

3 U.S.C. 57a).

Æ