II

106TH CONGRESS

2D SESSION S. 2379

To provide for the protection of children from tobacco.

IN THE SENATE OF THE UNITED STATES

APRIL 6, 2000

Mr. HARKIN (for himself, Mr. L. CHAFEE, and Mr. GRAHAM) introduced the

following bill; which was read twice and referred to the Committee on

Health, Education, Labor, and Pensions

A BILL

To provide for the protection of children from tobacco.

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 ‘‘Kids Deserve Freedom

5 from Tobacco Act of 2000’’ or the ‘‘KIDS Act’’.
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1 TITLE I—PROTECTION OF

2 CHILDREN FROM TOBACCO

3 Subtitle A—Food and Drug Admin4 istration Jurisdiction and Gen5 eral Authority

6 SEC. 101. REFERENCE.

7 Whenever in this title an amendment or repeal is ex8 pressed in terms of an amendment to, or repeal of, a sec9 tion or other provision, the reference shall be considered

10 to be made to a section or other provision of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

12 SEC. 102. STATEMENT OF GENERAL AUTHORITY.

13 The regulations promulgated by the Secretary in the

14 rule dated August 28, 1996 (Vol. 61, No. 168 C.F.R.),

15 adding part 897 to title 21, Code of Federal Regulations,

16 shall be deemed to have been lawfully promulgated under

17 the Food, Drug, and Cosmetic Act as amended by this

18 title. Such regulations shall apply to all tobacco products.

19 SEC. 103. NONAPPLICABILITY TO OTHER DRUGS OR DE20 VICES.

21 Nothing in this title, or an amendment made by this

22 title, shall be construed to affect the regulation of drugs

23 and devices that are not tobacco products by the Secretary

24 under the Federal Food, Drug, and Cosmetic Act.
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1 SEC. 104. CONFORMING AMENDMENTS TO CONFIRM JURIS2 DICTION.

3 (a) DEFINITIONS.—

4 (1) DRUG.—Section 201(g)(1) (21 U.S.C.

5 321(g)(1)) is amended by striking ‘‘; and (D)’’ and

6 inserting ‘‘; (D) nicotine in tobacco products; and

7 (E)’’.

8 (2) DEVICES.—Section 201(h) (21 U.S.C.

9 321(h)) is amended by adding at the end the fol10 lowing: ‘‘Such term includes a tobacco product.’’.

11 (3) OTHER DEFINITIONS.—Section 201 (21

12 U.S.C. 321) is amended by adding at the end the

13 following:

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

15 product made or derived from tobacco that is in16 tended for human consumption.’’.

17 (b) PROHIBITED ACTS.—Section 301 (21 U.S.C.

18 331) is amended by adding at the end the following:

19 ‘‘(aa) The manufacture, labeling, distribution, adver20 tising and sale of any adulterated or misbranded tobacco

21 product in violation of—

22 ‘‘(1) regulations issued under this Act; or

23 ‘‘(2) the KIDS Act, or regulations issued under

24 such Act.’’.

25 (c) ADULTERATED DRUGS AND DEVICES.—
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1 (1) IN GENERAL.—Section 501 of the Federal

2 Food, Drug, and Cosmetic Act (21 U.S.C. 351) is

3 amended by adding at the end the following:

4 ‘‘(j) If it is a tobacco product and it does not comply

5 with the provisions of subchapter D of this chapter or the

6 KIDS Act.’’.

7 (2) MISBRANDING.—Section 502(q) (21 U.S.C.

8 352(q)) is amended—

9 (A) by striking ‘‘or (2)’’ and inserting in

10 lieu thereof ‘‘(2)’’; and

11 (B) by inserting before the period the fol12 lowing: ‘‘, or (3) in the case of a tobacco prod13 uct, it is sold, distributed, advertised, labeled,

14 or used in violation of this Act or the KIDS

15 Act, or regulations prescribed under such

16 Acts’’.

17 (d) RESTRICTED DEVICE.—Section 520(e) (21

18 U.S.C. 360j(e)) is amended—

19 (1) in paragraph (1), by striking ‘‘or use—’’

20 and inserting ‘‘or use, including restrictions on the

21 access to, and the advertising and promotion of, to22 bacco products—’’; and

23 (2) by adding at the end the following:

24 ‘‘(3) Tobacco products are a restricted device under

25 this paragraph.’’.
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1 (e) REGULATORY AUTHORITY.—Section 503(g) (21

2 U.S.C. 353(g)) is amended by adding at the end the fol3 lowing:

4 ‘‘(5) The Secretary may regulate any tobacco product

5 as a drug, device, or both, and may designate the office

6 of the Administration that shall be responsible for regu7 lating such products.’’.

8 SEC. 105. GENERAL RULE.

9 Section 513(a)(1)(B) (21 U.S.C. 360c(a)(1)(B)) is

10 amended by adding at the end the following: ‘‘The sale

11 of tobacco products to adults that comply with perform12 ance standards established for these products under sec13 tion 514 and other provisions of this Act and any regula14 tions prescribed under this Act shall not be prohibited by

15 the Secretary, notwithstanding sections 502(j), 516, and

16 518.’’.

17 SEC. 106. SAFETY AND EFFICACY STANDARD AND RECALL

18 AUTHORITY.

19 (a) SAFETY AND EFFICACY STANDARD.—Section

20 513(a) (21 U.S.C. 360c(a)) is amended—

21 (1) in paragraph (1)(B), by inserting after the

22 first sentence the following: ‘‘For a device which is

23 a tobacco product, the assurance in the previous sen24 tence need not be found if the Secretary finds that
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1 special controls achieve the best public health re2 sult.’’; and

3 (2) in paragraph (2)—

4 (A) by redesignating subparagraphs (A),

5 (B) and (C) as clauses (i), (ii) and (iii), respec6 tively;

7 (B) by striking ‘‘(2) For’’ and inserting

8 ‘‘(2)(A) For’’; and

9 (C) by adding at the end the following:

10 ‘‘(B) For purposes of paragraph (1)(B), subsections

11 (c)(2)(C), (d)(2)(B), (e)(2)(A), (f)(3)(B)(i), and

12 (f)(3)(C)(i), and sections 514, 519(a), 520(e), and 520(f),

13 the safety and effectiveness of a device that is a tobacco

14 product need not be found if the Secretary finds that the

15 action to be taken under any such provision would achieve

16 the best public health result. The finding as to whether

17 the best public health result has been achieved shall be

18 determined with respect to the risks and benefits to the

19 population as a whole, including users and non-users of

20 the tobacco product, and taking into account—

21 ‘‘(i) the increased or decreased likelihood that

22 existing consumers of tobacco products will stop

23 using such products; and
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1 ‘‘(ii) the increased or decreased likelihood that

2 those who do not use tobacco products will start

3 using such products.’’.

4 (b) RECALL AUTHORITY.—Section 518(e)(1) (21

5 U.S.C. 360h(e)(1)) is amended by inserting after ‘‘adverse

6 health consequences or death,’’ the following: ‘‘and for to7 bacco products that the best public health result would

8 be achieved,’’.

9 Subtitle B—Regulation of Tobacco

10 Products

11 SEC. 111. PERFORMANCE STANDARDS.

12 Section 514(a) (21 U.S.C. 60d(a)) is amended—

13 (1) in paragraph (2), by striking ‘‘device’’ and

14 inserting ‘‘nontobacco product device’’;

15 (2) by redesignating paragraphs (3) and (4) as

16 paragraphs (6) and (7), respectively; and

17 (3) by inserting after paragraph (2) the fol18 lowing:

19 ‘‘(3) The Secretary may adopt a performance stand20 ard under section 514(a)(2) for a tobacco product regard21 less of whether the product has been classified under sec22 tion 513. Such standard may—

23 ‘‘(A) include provisions to achieve the best pub24 lic health result;
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1 ‘‘(B) where necessary to achieve the best public

2 health result, include—

3 ‘‘(i) provisions respecting the construction,

4 components, constituents, ingredients, and

5 properties of the tobacco product device, includ6 ing the reduction or elimination (or both) of

7 nicotine and the other components, ingredients,

8 and constituents of the tobacco product, its

9 components and its by-products, based upon the

10 best available technology;

11 ‘‘(ii) provisions for the testing (on a sam12 ple basis or, if necessary, on an individual

13 basis) of the tobacco product device or, if it is

14 determined that no other more practicable

15 means are available to the Secretary to assure

16 the conformity of the tobacco product device to

17 such standard, provisions for the testing (on a

18 sample basis or, if necessary, on an individual

19 basis) by the Secretary or by another person at

20 the direction of the Secretary;

21 ‘‘(iii) provisions for the measurement of

22 the performance characteristics of the tobacco

23 product device;

24 ‘‘(iv) provisions requiring that the results

25 of each test or of certain tests of the tobacco
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1 product device required to be made under

2 clause (ii) demonstrate that the tobacco product

3 device is in conformity with the portions of the

4 standard for which the test or tests were re5 quired; and

6 ‘‘(v) a provision that the sale and distribu7 tion of the tobacco product device be restricted

8 but only to the extent that the sale and dis9 tribution of a tobacco product device may other10 wise be restricted under this Act; and

11 ‘‘(C) where appropriate, require the use and

12 prescribe the form and content of labeling for the

13 use of the tobacco product device.

14 ‘‘(4) Not later than 1 year after the date of enact15 ment of the KIDS Act, the Secretary (acting through the

16 Commissioner of Food and Drugs) shall establish a Sci17 entific Advisory Committee to evaluate whether a level or

18 range of levels exists at which nicotine yields do not

19 produce drug-dependence. The Advisory Committee shall

20 also review any other safety, dependence or health issue

21 assigned to it by the Secretary. The Secretary need not

22 promulgate regulations to establish the Committee.’’.
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1 SEC. 112. APPLICATION OF FEDERAL FOOD, DRUG, AND

2 COSMETIC ACT TO TOBACCO PRODUCTS.

3 (a) TOBACCO PRODUCTS REGULATION.—Chapter V

4 (21 U.S.C. 351 et seq.) is amended by adding at the end

5 the following:

6 ‘‘SUBCHAPTER F—TOBACCO PRODUCT DEVEL7 OPMENT, MANUFACTURING, AND ACCESS

8 RESTRICTIONS

9 ‘‘SEC. 570. PROMULGATION OF REGULATIONS.

10 ‘‘Any regulations necessary to implement this sub11 chapter shall be promulgated not later than 12 months

12 after the date of enactment of this subchapter using notice

13 and comment rulemaking (in accordance with chapter 5

14 of title 5, United States Code). Such regulations may be

15 revised thereafter as determined necessary by the Sec16 retary.

17 ‘‘SEC. 571. MAIL-ORDER SALES.

18 ‘‘(a) IN GENERAL.—Not later than 2 years after the

19 date of enactment of this subchapter, the Secretary shall

20 review and determine whether persons under the age of

21 18 years are obtaining tobacco products by means of the

22 mail.

23 ‘‘(b) RESTRICTIONS.—Based solely upon the review

24 conducted under subsection (a), the Secretary may take

25 regulatory and administrative action to restrict or elimi26 nate mail order sales of tobacco products.
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1 ‘‘SEC. 572. IMPLEMENTATION OF THE PROPOSED RESOLU2 TION.

3 ‘‘(a) ADDITIONAL RESTRICTIONS ON MARKETING,

4 ADVERTISING, AND ACCESS.—Not later than 18 months

5 after the date of the enactment of this subchapter, the

6 Secretary shall revise the regulations related to tobacco

7 products promulgated by the Secretary on August 28,

8 1996 (61 Fed. Reg. 44396) to include the additional re9 strictions on marketing, advertising, and access described

10 in Title IA and Title IC of the Proposed Resolution en11 tered into by the tobacco manufacturers and the State at12 torneys general on June 20, 1997, except that the Sec13 retary shall not include an additional restriction on mar14 keting or advertising in such regulations if its inclusion

15 would violate the First Amendment to the Constitution.

16 ‘‘(b) WARNINGS.—Not later than 18 months after the

17 date of the enactment of this subchapter, the Secretary

18 shall promulgate regulations to require warnings on ciga19 rette and smokeless tobacco labeling and advertisements.

20 The content, format, and rotation of warnings shall con21 form to the specifications described in Title IB of the Pro22 posed Resolution entered into by the tobacco manufactur23 ers and the State attorneys general on June 20, 1997.

24 ‘‘(c) RULES OF CONSTRUCTION.—

25 ‘‘(1) IN GENERAL.—Nothing in this section

26 shall be construed to limit the ability of the Sec-
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1 retary to change the text or layout of any of the

2 warning statements, or any of the labeling provi3 sions, under the regulations promulgated under sub4 section (b) and other provisions of this Act, if deter5 mined necessary by the Secretary in order to make

6 such statements or labels larger, more prominent,

7 more conspicuous, or more effective.

8 ‘‘(2) UNFAIR ACTS.—Nothing in this section

9 (other than the requirements of subsections (a) and

10 (b)) shall be construed to limit or restrict the au11 thority of the Federal Trade Commission with re12 spect to unfair or deceptive acts or practices in the

13 advertising of tobacco products.

14 ‘‘(d) LIMITED PREEMPTION.—

15 ‘‘(1) STATE AND LOCAL ACTION.—No warning

16 label with respect to tobacco products, or any other

17 tobacco product for which warning labels have been

18 required under this section, other than the warning

19 labels required under this Act, shall be required by

20 any State or local statute or regulation to be in21 cluded on any package of a tobacco product.

22 ‘‘(2) EFFECT ON LIABILITY LAW.—Nothing in

23 this section shall relieve any person from liability at

24 common law or under State statutory law to any

25 other person.
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1 ‘‘(e) VIOLATION OF SECTION.—Any tobacco product

2 that is in violation of this section shall be deemed to be

3 misbranded.

4 ‘‘SEC. 573. GENERAL RESPONSIBILITIES OF MANUFACTUR5 ERS, DISTRIBUTORS AND RETAILERS.

6 ‘‘Each manufacturer, distributor, and retailer shall

7 ensure that the tobacco products it manufactures, labels,

8 advertises, packages, distributes, sells, or otherwise holds

9 for sale comply with all applicable requirements of this

10 Act.

11 ‘‘SEC. 574. DISCLOSURE AND REPORTING OF TOBACCO AND

12 NONTOBACCO INGREDIENTS AND CONSTITU13 ENTS.

14 ‘‘(a) DISCLOSURE OF ALL INGREDIENTS.—

15 ‘‘(1) IMMEDIATE AND ANNUAL DISCLOSURE.—

16 Not later than 30 days after the date of enactment

17 of this subchapter, and annually thereafter, each

18 manufacturer of a tobacco product shall submit to

19 the Secretary an ingredient list for each brand of to20 bacco product it manufactures that contains the in21 formation described in paragraph (2).

22 ‘‘(2) REQUIREMENTS.—The list described in

23 paragraph (1) shall, with respect to each brand or

24 variety of tobacco product of a manufacturer,

25 include—
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1 ‘‘(A) a list of all ingredients, constituents,

2 substances, and compounds that are found in or

3 added to the tobacco or tobacco product (in4 cluding the paper, filter, or packaging of the

5 product if applicable) in the manufacture of the

6 tobacco product, for each brand or variety of to7 bacco product so manufactured, including, if

8 determined necessary by the Secretary, any ma9 terial added to the tobacco used in the product

10 prior to harvesting;

11 ‘‘(B) the quantity of the ingredients, con12 stituents, substances, and compounds that are

13 listed under subparagraph (A) in each brand or

14 variety of tobacco product;

15 ‘‘(C) the nicotine content of the product,

16 measured in milligrams of nicotine;

17 ‘‘(D) for each brand or variety of

18 cigarettes—

19 ‘‘(i) the filter ventilation percentage

20 (the level of air dilution in the cigarette as

21 provided by the ventilation holes in the fil22 ter, described as a percentage);

23 ‘‘(ii) the pH level of the smoke of the

24 cigarette; and
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1 ‘‘(iii) the tar, unionized (free) nico2 tine, and carbon monoxide delivery level

3 and any other smoking conditions estab4 lished by the Secretary, reported in milli5 grams of tar, nicotine, and carbon mon6 oxide per cigarette;

7 ‘‘(E) for each brand or variety of smoke8 less tobacco products—

9 ‘‘(i) the pH level of the tobacco;

10 ‘‘(ii) the moisture content of the to11 bacco expressed as a percentage of the

12 weight of the tobacco; and

13 ‘‘(iii) the nicotine content—

14 ‘‘(I) for each gram of the prod15 uct, measured in milligrams of nico16 tine;

17 ‘‘(II) expressed as a percentage

18 of the dry weight of the tobacco; and

19 ‘‘(III) with respect to unionized

20 (free) nicotine, expressed as a percent21 age per gram of the tobacco and ex22 pressed in milligrams per gram of the

23 tobacco; and

24 ‘‘(F) any other information determined ap25 propriate by the Secretary.
16

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1 ‘‘(3) METHODS.—The Secretary shall have the

2 authority to promulgate regulations to establish the

3 methods to be used by manufacturers in making the

4 determinations required under paragraph (2).

5 ‘‘(4) OTHER TOBACCO PRODUCTS.—The Sec6 retary shall prescribe such regulations as may be

7 necessary to establish information disclosure proce8 dures for other tobacco products.

9 ‘‘(b) SAFETY ASSESSMENTS.—

10 ‘‘(1) APPLICATION TO NEW INGREDIENTS.—

11 ‘‘(A) IN GENERAL.—Not later than 1 year

12 after the date of enactment of this subchapter,

13 and annually thereafter, each manufacturer

14 shall submit to the Secretary a safety assess15 ment for each new ingredient, constituent, sub16 stance, or compound that such manufacturer

17 desires to make a part of a tobacco product.

18 Such new ingredient, constituent, substance, or

19 compound shall not be included in a tobacco

20 product prior to approval by the Secretary of

21 such a safety assessment.

22 ‘‘(B) METHOD OF FILING.—A safety as23 sessment submitted under subparagraph (A)

24 shall be signed by an officer of the manufac25 turer who is acting on behalf of the manufac-
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1 turer and who has the authority to bind the

2 manufacturer, and contain a statement that en3 sures that the information contained in the as4 sessment is true, complete and accurate.

5 ‘‘(C) DEFINITION OF NEW INGREDIENT.—

6 For purposes of subparagraph (A), the term

7 ‘new ingredient, constituent, substance, or com8 pound’ means an ingredient, constituent, sub9 stance, or compound listed under subsection

10 (a)(1) that was not used in the brand or variety

11 of tobacco product involved prior to January 1,

12 1998.

13 ‘‘(2) APPLICATION TO OTHER INGREDIENTS.—

14 With respect to the application of this section to in15 gredients, constituents substances, or compounds

16 listed under subsection (a) to which paragraph (1)

17 does not apply, all such ingredients, constituents,

18 substances, or compounds shall be reviewed through

19 the safety assessment process within the 5-year pe20 riod beginning on the date of enactment of this sub21 chapter. The Secretary shall develop a procedure for

22 the submission of safety assessments of such ingre23 dients, constituents, substances, or compounds that

24 staggers such safety assessments within the 5-year

25 period.
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1 ‘‘(3) BASIS OF ASSESSMENT.—The safety as2 sessment of an ingredient, constituent, substance, or

3 compound described in paragraphs (1) and (2)

4 shall—

5 ‘‘(A) be based on the best scientific evi6 dence available at the time of the submission of

7 the assessment; and

8 ‘‘(B) demonstrate that there is a reason9 able certainty among experts qualified by sci10 entific training and experience who are con11 sulted, that the ingredient, constituent, sub12 stance, or compound will not present any risk

13 to consumers or the public in the quantities

14 used under the intended conditions of use.

15 ‘‘(c) PROHIBITION.—

16 ‘‘(1) REGULATIONS.—Not later than 12 months

17 after the date of enactment of this subchapter, the

18 Secretary shall promulgate regulations to prohibit

19 the use of any ingredient, constituent, substance, or

20 compound in the tobacco product of a

21 manufacturer—

22 ‘‘(A) if no safety assessment has been sub23 mitted by the manufacturer for the ingredient,

24 constituent, substance, or compound as other25 wise required under this section; or
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1 ‘‘(B) if the Secretary finds that the manu2 facturer has failed to demonstrate the safety of

3 the ingredient, constituent, substance, or com4 pound that was the subject of the assessment

5 under paragraph (2).

6 ‘‘(2) REVIEW OF ASSESSMENTS.—

7 ‘‘(A) GENERAL REVIEW.—Not later than

8 180 days after the receipt of a safety assess9 ment under subsection (b), the Secretary shall

10 review the findings contained in such assess11 ment and approve or disapprove of the safety of

12 the ingredient, constituent, substance, or com13 pound that was the subject of the assessment.

14 The Secretary may, for good cause, extend the

15 period for such review. The Secretary shall pro16 vide notice to the manufacturer of an action

17 under this subparagraph.

18 ‘‘(B) INACTION BY SECRETARY.—If the

19 Secretary fails to act with respect to an assess20 ment of an existing ingredient, constituent, sub21 stance, or additive during the period referred to

22 in subparagraph (A), the manufacturer of the

23 tobacco product involved may continue to use

24 the ingredient, constituent, substance, or com25 pound involved until such time as the Secretary
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1 makes a determination with respect to the as2 sessment.

3 ‘‘(d) RIGHT TO KNOW; FULL DISCLOSURE OF INGRE4 DIENTS TO THE PUBLIC.—

5 ‘‘(1) IN GENERAL.—Except as provided in para6 graph (3), a package of a tobacco product shall dis7 close all ingredients, constituents, substances, or

8 compounds contained in the product in accordance

9 with regulations promulgated under section 701(a)

10 by the Secretary.

11 ‘‘(2) DISCLOSURE OF PERCENTAGE OF DOMES12 TIC AND FOREIGN TOBACCO.—The regulations re13 ferred to in paragraph (1) shall require that the

14 package of a tobacco product disclose, with respect

15 to the tobacco contained in the product—

16 ‘‘(A) the percentage that is domestic to17 bacco; and

18 ‘‘(B) the percentage that is foreign to19 bacco.

20 ‘‘(3) HEALTH DISCLOSURE.—Notwithstanding

21 section 301(j), the Secretary may require the public

22 disclosure of any ingredient, constituent, substance,

23 or compound contained in a tobacco product that re24 lates to a trade secret or other matter referred to in

25 section 1905 of title 18, United States Code, if the
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1 Secretary determines that such disclosure will pro2 mote the public health.

3 ‘‘SEC. 575. REDUCED RISK PRODUCTS.

4 ‘‘(a) PROHIBITION.—

5 ‘‘(1) IN GENERAL.—No manufacturer, dis6 tributor or retailer of tobacco products may make

7 any direct or implied statement in advertising or on

8 a product package that could reasonably be inter9 preted to state or imply a reduced health risk associ10 ated with a tobacco product unless the manufacturer

11 demonstrates to the Secretary, in such form as the

12 Secretary may require, that based on the best avail13 able scientific evidence the product significantly re14 duces the overall health risk to the public when com15 pared to other tobacco products.

16 ‘‘(2) SUBMISSION TO SECRETARY.—Prior to

17 making any statement described in paragraph (1), a

18 manufacturer, distributor or retailer shall submit

19 such statement to the Secretary, who shall review

20 such statement to ensure its accuracy and, in the

21 case of advertising, to prevent such statement from

22 increasing, or preventing the contraction of, the size

23 of the overall market for tobacco products.

24 ‘‘(b) DETERMINATION BY SECRETARY.—If the Sec25 retary determines that a statement described in subsection
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1 (a)(2) is permissible because the tobacco product does

2 present a significantly reduced overall health risk to the

3 public, the Secretary may permit such statement to be

4 made.

5 ‘‘(c) DEVELOPMENT OR ACQUISITION OF REDUCED

6 RISK TECHNOLOGY.—

7 ‘‘(1) IN GENERAL.—Any manufacturer that de8 velops or acquires any technology that the manufac9 turer reasonably believes will reduce the risk from

10 tobacco products shall notify the Secretary of the de11 velopment or acquisition of the technology. Such no12 tice shall be in such form and within such time as

13 the Secretary shall require.

14 ‘‘(2) CONFIDENTIALITY.—With respect to any

15 technology described in paragraph (1) that is in the

16 early stages of development (as determined by the

17 Secretary), the Secretary shall establish protections

18 to ensure the confidentiality of any proprietary in19 formation submitted to the Secretary under this sub20 section during such development.

21 ‘‘SEC. 576. ACCESS TO COMPANY INFORMATION.

22 ‘‘(a) COMPLIANCE PROCEDURES.—Each manufac23 turer of tobacco products shall establish procedures to en24 sure compliance with this Act.
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1 ‘‘(b) REQUIREMENT.—In addition to any other dis2 closure obligations under this Act, the KIDS Act, or any

3 other law, each manufacturer of tobacco products shall,

4 not later than 90 days after the date of the enactment

5 of the KIDS Act and thereafter as required by the Sec6 retary, disclose to the Secretary all nonpublic information

7 and research in its possession or control relating to the

8 addiction or dependency, or the health or safety of tobacco

9 products, including (without limitation) all research relat10 ing to processes to make tobacco products less hazardous

11 to consumers and the research and documents described

12 in subsection (c).

13 ‘‘(c) RESEARCH AND DOCUMENTS.—The documents

14 described in this section include any documents concerning

15 tobacco product research relating to—

16 ‘‘(1) nicotine, including—

17 ‘‘(A) the interaction between nicotine and

18 other components in tobacco products including

19 ingredients in the tobacco and smoke compo20 nents;

21 ‘‘(B) the role of nicotine in product design

22 and manufacture, including product charters,

23 and parameters in product development, the to24 bacco blend, filter technology, and paper;
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1 ‘‘(C) the role of nicotine in tobacco leaf

2 purchasing;

3 ‘‘(D) reverse engineering activities involv4 ing nicotine (such as analyzing the products of

5 other companies);

6 ‘‘(E) an analysis of nicotine delivery; and

7 ‘‘(F) the biology, psychopharmacology and

8 any other health effects of nicotine;

9 ‘‘(2) other ingredients, including—

10 ‘‘(A) the identification of ingredients in to11 bacco products and constituents in smoke, in12 cluding additives used in product components

13 such as paper, filter, and wrapper;

14 ‘‘(B) any research on the health effects of

15 ingredients; and

16 ‘‘(C) any research or other information ex17 plaining what happens to ingredients when they

18 are heated and burned;

19 ‘‘(3) less hazardous or safer products, including

20 any research or product development information on

21 activities involving reduced risk, less hazardous, low22 tar or reduced-tar, low-nicotine or reduced-nicotine

23 or nicotine-free products; and

24 ‘‘(4) tobacco product advertising, marketing

25 and promotion, including—
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1 ‘‘(A) documents related to the design of

2 advertising campaigns, including the desired de3 mographics for individual products on the mar4 ket or being tested;

5 ‘‘(B) documents concerning the age of ini6 tiation of tobacco use, general tobacco use be7 havior, beginning smokers, pre-smokers, and

8 new smokers;

9 ‘‘(C) documents concerning the effects of

10 advertising; and

11 ‘‘(D) documents concerning future mar12 keting options or plans in light of the require13 ments and regulations to be imposed under this

14 subchapter or the KIDS Act.

15 ‘‘(d) AUTHORITY OF SECRETARY.—With respect to

16 tobacco product manufacturers, the Secretary shall have

17 the same access to records and information and inspection

18 authority as is available with respect to manufacturers of

19 other medical devices.

20 ‘‘SEC. 577. OVERSIGHT OF TOBACCO PRODUCT MANUFAC21 TURING.

22 ‘‘The Secretary shall by regulation prescribe good

23 manufacturing practice standards for tobacco products.

24 Such regulations shall be modeled after good manufac25 turing practice regulations for medical devices, food, and
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1 other items under section 520(f). Such standards shall be

2 directed specifically toward tobacco products, and shall

3 include—

4 ‘‘(1) a quality control system, to ensure that to5 bacco products comply with such standards;

6 ‘‘(2) a system for inspecting tobacco product

7 materials to ensure their compliance with such

8 standards;

9 ‘‘(3) requirements for the proper handling of

10 finished tobacco products;

11 ‘‘(4) strict tolerances for pesticide chemical resi12 dues in or on tobacco or tobacco product commod13 ities in the possession of the manufacturer, except

14 that nothing in this paragraph shall be construed to

15 affect any authority of the Environmental Protection

16 Agency;

17 ‘‘(5) authority for officers or employees of the

18 Secretary to inspect any factory, warehouse, or other

19 establishment of any tobacco product manufacturer,

20 and to have access to records, files, papers, proc21 esses, controls and facilities related to tobacco prod22 uct manufacturing, in accordance with appropriate

23 authority and rules promulgated under this Act; and

24 ‘‘(6) a requirement that the tobacco product

25 manufacturer maintain such files and records as the
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1 Secretary may specify, as well as that the manufac2 turer report to the Secretary such information as

3 the Secretary shall require, in accordance with sec4 tion 519.

5 ‘‘SEC. 578. PRESERVATION OF STATE AND LOCAL AUTHOR6 ITY.

7 ‘‘Notwithstanding section 521 and except as other8 wise provided for in section 572(e), nothing in this sub9 chapter shall be construed as prohibiting a State or local10 ity from imposing requirements, prohibitions, penalties or

11 other measures to further the purposes of this subchapter

12 that are in addition to the requirements, prohibitions, or

13 penalties required under this subchapter. State and local

14 governments may impose additional tobacco product con15 trol measures to further restrict or limit the use of such

16 products.’’.

17 SEC. 113. FUNDING.

18 (a) AUTHORIZATION OF APPROPRIATIONS.—There

19 are authorized to be appropriated such sums as may be

20 necessary to carry out this subtitle (and the amendments

21 made by this subtitle).

22 (b) TRIGGER.—No expenditures shall be made under

23 this subtitle (or the amendments made by this subtitle)

24 during any fiscal year in which the annual amount appro-
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1 priated for the Food and Drug Administration is less than

2 the amount so appropriated for the prior fiscal year.

3 SEC. 114. REPEALS.

4 The following provisions of law are repealed:

5 (1) The Federal Cigarette Labeling and Adver6 tising Act (15 U.S.C. 1331 et seq.), except for sec7 tions 5(d)(1) and (2) and 6.

8 (2) The Comprehensive Smokeless Tobacco

9 Health Education Act of 1986 (15 U.S.C. 4401 et

10 seq.), except for sections 3(f) and 8(a) and (b).

11 (3) The Comprehensive Smoking Education Act

12 of 1964 (Public law 98-474).

13 TITLE II—MISCELLANEOUS

14 PROVISIONS

15 SEC. 201. NONAPPLICATION TO TOBACCO PRODUCERS.

16 (a) IN GENERAL.—This Act and the amendments

17 made by this Act shall not apply to the producers of to18 bacco leaf, including tobacco growers, tobacco warehouses,

19 and tobacco grower cooperatives.

20 (b) RULE OF CONSTRUCTION.—Nothing in this Act,

21 or an amendment made by this Act, shall be construed

22 to provide the Secretary of Health and Human Services

23 with the authority to—
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1 (1) enter onto a farm owned by a producer of

2 tobacco leaf without the written consent of such pro3 ducer; or

4 (2) promulgate regulations on any matter that

5 involves the production of tobacco leaf or a producer

6 thereof, other than activities by a manufacturer that

7 affect production.

8 (c) MANUFACTURER ACTING AS PRODUCER.—Not9 withstanding any other provision of this section, if a pro10 ducer of tobacco leaf is also a tobacco product manufac11 turer or is owned or controlled by a tobacco product manu12 facturer, the producer shall be subject to the provisions

13 of this Act, and the amendments made by this Act, in the

14 producer’s capacity as a manufacturer.

15 (d) DEFINITION.—In this section, the term ‘‘con16 trolled by’’ means a producer that is a member of the same

17 controlled group of corporations, as that term is used for

18 purposes of section 52(a) of the Internal Revenue Code

19 of 1986, or under common control within the meaning of

20 the regulations promulgated under section 52(b) of such

21 Code.

22 SEC. 202. EQUAL TREATMENT OF RETAIL OUTLETS.

23 The Secretary of Health and Human Services shall

24 promulgate regulations to require that retail establish25 ments that are accessible to individuals under the age of
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1 18, for which the predominant business is the sale of to2 bacco products, comply with any advertising restrictions

3 applicable to such establishments.

Æ