2000
<PRE>[DOCID: f:s247is.txt]






107th CONGRESS
  1st Session
                                 S. 247

        To provide for the protection of children from tobacco.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 6, 2001

Mr. Harkin (for himself, Mr. Chafee, Mr. Graham, Mr. Bingaman, and Mr. 
   Johnson) 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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Kids Deserve Freedom from Tobacco 
Act of 2001'' or the ``KIDS Act''.

              TITLE I--PROTECTION OF CHILDREN FROM TOBACCO

   Subtitle A--Food and Drug Administration Jurisdiction and General 
                               Authority

SEC. 101. REFERENCE.

    Whenever in this title an amendment or repeal is expressed in terms 
of an amendment to, or repeal of, a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.).

SEC. 102. STATEMENT OF GENERAL AUTHORITY.

    The regulations promulgated by the Secretary of Health and Human 
Services in the rule dated August 28, 1996 (Vol. 61, No. 168 C.F.R.), 
adding part 897 to title 21, Code of Federal Regulations, shall be 
deemed to have been lawfully promulgated under the Food, Drug, and 
Cosmetic Act as amended by this title. Such regulations shall apply to 
all tobacco products.

SEC. 103. NONAPPLICABILITY TO OTHER DRUGS OR DEVICES.

    Nothing in this title, or an amendment made by this title, shall be 
construed to affect the regulation of drugs and devices that are not 
tobacco products by the Secretary of Health and Human Services under 
the Federal Food, Drug, and Cosmetic Act.

SEC. 104. CONFORMING AMENDMENTS TO CONFIRM JURISDICTION.

    (a) Definitions.--
            (1) Drug.--Section 201(g)(1) (21 U.S.C. 321(g)(1)) is 
        amended by striking ``; and (D)'' and inserting ``; (D) 
        nicotine in tobacco products; and (E)''.
            (2) Devices.--Section 201(h) (21 U.S.C. 321(h)) is amended 
        by adding at the end the following: ``Such term includes a 
        tobacco product.''.
            (3) Other definitions.--Section 201 (21 U.S.C. 321) is 
        amended by adding at the end the following:
            ``(kk) The term `tobacco product' means any product made or 
        derived from tobacco that is intended for human consumption.''.
    (b) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(aa) The manufacture, labeling, distribution, advertising and 
sale of any adulterated or misbranded tobacco product in violation of--
            ``(1) regulations issued under this Act; or
            ``(2) the KIDS Act, or regulations issued under such 
        Act.''.
    (c) Adulterated Drugs and Devices.--
            (1) In general.--Section 501 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 351) is amended by adding at the end 
        the following:
    ``(j) If it is a tobacco product and it does not comply with the 
provisions of subchapter D of this chapter or the KIDS Act.''.
            (2) Misbranding.--Section 502(q) (21 U.S.C. 352(q)) is 
        amended--
                    (A) by striking ``or (2)'' and inserting ``(2)''; 
                and
                    (B) by inserting before the period the following: 
                ``, or (3) in the case of a tobacco product, it is 
                sold, distributed, advertised, labeled, or used in 
                violation of this Act or the KIDS Act, or regulations 
                prescribed under such Acts''.
    (d) Restricted Device.--Section 520(e) (21 U.S.C. 360j(e)) is 
amended--
            (1) in paragraph (1), by striking ``or use--'' and 
        inserting ``or use, including restrictions on the access to, 
        and the advertising and promotion of, tobacco products--''; and
            (2) by adding at the end the following:
    ``(3) Tobacco products are a restricted device under this 
paragraph.''.
    (e) Regulatory Authority.--Section 503(g) (21 U.S.C. 353(g)) is 
amended by adding at the end the following:
    ``(5) The Secretary may regulate any tobacco product as a drug, 
device, or both, and may designate the office of the Administration 
that shall be responsible for regulating such products.''.

SEC. 105. GENERAL RULE.

    Section 513(a)(1)(B) (21 U.S.C. 360c(a)(1)(B)) is amended by adding 
at the end the following: ``The sale of tobacco products to adults that 
comply with performance standards established for these products under 
section 514 and other provisions of this Act and any regulations 
prescribed under this Act shall not be prohibited by the Secretary, 
notwithstanding sections 502(j), 516, and 518.''.

SEC. 106. SAFETY AND EFFICACY STANDARD AND RECALL AUTHORITY.

    (a) Safety and Efficacy Standard.--Section 513(a) (21 U.S.C. 
360c(a)) is amended--
            (1) in paragraph (1)(B), by inserting after the first 
        sentence the following: ``For a device which is a tobacco 
product, the assurance in the previous sentence need not be found if 
the Secretary finds that special controls achieve the best public 
health result.''; and
            (2) in paragraph (2)--
                    (A) by redesignating subparagraphs (A), (B) and (C) 
                as clauses (i), (ii) and (iii), respectively;
                    (B) by striking ``(2) For'' and inserting ``(2)(A) 
                For''; and
                    (C) by adding at the end the following:
    ``(B) For purposes of paragraph (1)(B), subsections (c)(2)(C), 
(d)(2)(B), (e)(2)(A), (f)(3)(B)(i), and (f)(3)(C)(i), and sections 514, 
519(a), 520(e), and 520(f), the safety and effectiveness of a device 
that is a tobacco product need not be found if the Secretary finds that 
the action to be taken under any such provision would achieve the best 
public health result. The finding as to whether the best public health 
result has been achieved shall be determined with respect to the risks 
and benefits to the population as a whole, including users and non-
users of the tobacco product, and taking into account--
            ``(i) the increased or decreased likelihood that existing 
        consumers of tobacco products will stop using such products; 
        and
            ``(ii) the increased or decreased likelihood that those who 
        do not use tobacco products will start using such products.''.
    (b) Recall Authority.--Section 518(e)(1) (21 U.S.C. 360h(e)(1)) is 
amended by inserting after ``adverse health consequences or death,'' 
the following: ``and for tobacco products that the best public health 
result would be achieved,''.

               Subtitle B--Regulation of Tobacco Products

SEC. 111. PERFORMANCE STANDARDS.

    Section 514(a) (21 U.S.C. 60d(a)) is amended--
            (1) in paragraph (2), by striking ``device'' and inserting 
        ``nontobacco product device'';
            (2) by redesignating paragraphs (3) and (4) as paragraphs 
        (5) and (6), respectively; and
            (3) by inserting after paragraph (2) the following:
    ``(3) The Secretary may adopt a performance standard under section 
514(a)(2) for a tobacco product regardless of whether the product has 
been classified under section 513. Such standard may--
            ``(A) include provisions to achieve the best public health 
        result;
            ``(B) where necessary to achieve the best public health 
        result, include--
                    ``(i) provisions respecting the construction, 
                components, constituents, ingredients, and properties 
                of the tobacco product device
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, including the reduction 
                or elimination (or both) of nicotine and the other 
                components, ingredients, and constituents of the 
                tobacco product, its components and its by-products, 
                based upon the best available technology;
                    ``(ii) provisions for the testing (on a sample 
                basis or, if necessary, on an individual basis) of the 
                tobacco product device or, if it is determined that no 
                other more practicable means are available to the 
                Secretary to assure the conformity of the tobacco 
                product device to such standard, provisions for the 
                testing (on a sample basis or, if necessary, on an 
                individual basis) by the Secretary or by another person 
                at the direction of the Secretary;
                    ``(iii) provisions for the measurement of the 
                performance characteristics of the tobacco product 
                device;
                    ``(iv) provisions requiring that the results of 
                each test or of certain tests of the tobacco product 
                device required to be made under clause (ii) 
                demonstrate that the tobacco product device is in 
                conformity with the portions of the standard for which 
                the test or tests were required; and
                    ``(v) a provision that the sale and distribution of 
                the tobacco product device be restricted but only to 
                the extent that the sale and distribution of a tobacco 
                product device may otherwise be restricted under this 
                Act; and
            ``(C) where appropriate, require the use and prescribe the 
        form and content of labeling for the use of the tobacco product 
        device.
    ``(4) Not later than 1 year after the date of enactment of the KIDS 
Act, the Secretary (acting through the Commissioner of Food and Drugs) 
shall establish a Scientific Advisory Committee to evaluate whether a 
level or range of levels exists at which nicotine yields do not produce 
drug-dependence. The Advisory Committee shall also review any other 
safety, dependence or health issue assigned to it by the Secretary. The 
Secretary need not promulgate regulations to establish the 
Committee.''.

SEC. 112. APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT TO 
              TOBACCO PRODUCTS.

    (a) Tobacco Products Regulation.--Chapter V (21 U.S.C. 351 et seq.) 
is amended by adding at the end the following:

``SUBCHAPTER F--TOBACCO PRODUCT DEVELOPMENT, MANUFACTURING, AND ACCESS 
                              RESTRICTIONS

``SEC. 570. PROMULGATION OF REGULATIONS.

    ``Any regulations necessary to implement this subchapter shall be 
promulgated not later than 12 months after the date of enactment of 
this subchapter using notice and comment rulemaking (in accordance with 
chapter 5 of title 5, United States Code). Such regulations may be 
revised thereafter as determined necessary by the Secretary.

``SEC. 571. MAIL-ORDER SALES.

    ``(a) In General.--Not later than 2 years after the date of 
enactment of this subchapter, the Secretary shall review and determine 
whether persons under the age of 18 years are obtaining tobacco 
products by means of the mail.
    ``(b) Restrictions.--Based solely upon the review conducted under 
subsection (a), the Secretary may take regulatory and administrative 
action to restrict or eliminate mail order sales of tobacco products.

``SEC. 572. IMPLEMENTATION OF THE PROPOSED RESOLUTION.

    ``(a) Additional Restrictions on Marketing, Advertising, and 
Access.--Not later than 18 months after the date of the enactment of 
this subchapter, the Secretary shall revise the regulations related to 
tobacco products promulgated by the Secretary on August 28, 1996 (61 
Fed. Reg. 44396) to include the additional restrictions on marketing, 
advertising, and access described in Title IA and Title IC of the 
Proposed Resolution entered into by the tobacco manufacturers and the 
State attorneys general on June 20, 1997, except that the Secretary 
shall not include an additional restriction on marketing or advertising 
in such regulations if its inclusion would violate the First Amendment 
to the Constitution.
    ``(b) Warnings.--Not later than 18 months after the date of the 
enactment of this subchapter, the Secretary shall promulgate 
regulations to require warnings on cigarette and smokeless tobacco 
labeling and advertisements. The content, format, and rotation of 
warnings shall conform to the specifications described in Title IB of 
the Proposed Resolution entered into by the tobacco manufacturers and 
the State attorneys general on June 20, 1997.
    ``(c) Rules of Construction.--
            ``(1) In general.--Nothing in this section shall be 
        construed to limit the ability of the Secretary to change the 
        text or layout of any of the warning statements, or any of the 
        labeling provisions, under the regulations promulgated under 
        subsection (b) and other provisions of this Act, if determined 
        necessary by the Secretary in order to make such statements or 
        labels larger, more prominent, more conspicuous, or more 
        effective.
            ``(2) Unfair acts.--Nothing in this section (other than the 
        requirements of subsections (a) and (b)) shall be construed to 
        limit or restrict the authority of the Federal Trade Commission 
        with respect to unfair or deceptive acts or practices in the 
        advertising of tobacco products.
    ``(d) Limited Preemption.--
            ``(1) State and local action.--No warning label with 
        respect to tobacco products, or any other tobacco product for 
        which warning labels have been required under this section, 
        other than the warning labels required under this Act, shall be 
        required by any State or local statute or regulation to be 
        included on any package of a tobacco product.
            ``(2) Effect on liability law.--Nothing in this section 
        shall relieve any person from liability at common law or under 
        State statutory law to any other person.
    ``(e) Violation of Section.--Any tobacco product that is in 
violation of this section shall be deemed to be misbranded.

``SEC. 573. GENERAL RESPONSIBILITIES OF MANUFACTURERS, DISTRIBUTORS AND 
              RETAILERS.

    ``Each manufacturer, distributor, and retailer shall ensure that 
the tobacco products it manufactures, labels, advertises, packages, 
distributes, sells, or otherwise holds for sale comply with all 
applicable requirements of this Act.

``SEC. 574. DISCLOSURE AND REPORTING OF TOBACCO AND NONTOBACCO 
              INGREDIENTS AND CONSTITUENTS.

    ``(a) Disclosure of All Ingredients.--
            ``(1) Immediate and annual disclosure.--Not later than 30 
        days after the date of enactment of this subchapter, and 
        annually thereafter, each manufacturer of a tobacco product 
        shall submit to the Secretary an ingredient list for each brand 
        of tobacco product it manufactures that contains the 
        information described in paragraph (2).
            ``(2) Requirements.--The list described in paragraph (1) 
        shall, with respect to each brand or variety of tobacco product 
        of a manufacturer, include--
                    ``(A) a list of all ingredients, constituents, 
                substances, and compounds that are found in or added to 
                the tobacco or tobacco product (including the paper, 
                filter, or packaging of the product if applicable) in 
                the manufacture of the tobacco product, for each brand 
                or variety of tobacco product so manufactured, 
                including, if determined necessary by the Secretary, 
                any material added to the tobacco used in the product 
                prior to harvesting;
                    ``(B) the quantity of the ingredients, 
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                constituents, substances, and compounds that are listed 
                under subparagraph (A) in each brand or variety of 
                tobacco product;
                    ``(C) the nicotine content of the product, measured 
                in milligrams of nicotine;
                    ``(D) for each brand or variety of cigarettes--
                            ``(i) the filter ventilation percentage 
                        (the level of air dilution in the cigarette as 
                        provided by the ventilation holes in the 
                        filter, described as a percentage);
                            ``(ii) the pH level of the smoke of the 
                        cigarette; and
                            ``(iii) the tar, unionized (free) nicotine, 
                        and carbon monoxide delivery level and any 
                        other smoking conditions established by the 
                        Secretary, reported in milligrams of tar, 
                        nicotine, and carbon monoxide per cigarette;
                    ``(E) for each brand or variety of smokeless 
                tobacco products--
                            ``(i) the pH level of the tobacco;
                            ``(ii) the moisture content of the tobacco 
                        expressed as a percentage of the weight of the 
                        tobacco; and
                            ``(iii) the nicotine content--
                                    ``(I) for each gram of the product, 
                                measured in milligrams of nicotine;
                                    ``(II) expressed as a percentage of 
                                the dry weight of the tobacco; and
                                    ``(III) with respect to unionized 
                                (free) nicotine, expressed as a 
                                percentage per gram of the tobacco and 
                                expressed in milligrams per gram of the 
                                tobacco; and
                    ``(F) any other information determined appropriate 
                by the Secretary.
            ``(3) Methods.--The Secretary shall have the authority to 
        promulgate regulations to establish the methods to be used by 
        manufacturers in making the determinations required under 
        paragraph (2).
            ``(4) Other tobacco products.--The Secretary shall 
        prescribe such regulations as may be necessary to establish 
        information disclosure procedures for other tobacco products.
    ``(b) Safety Assessments.--
            ``(1) Application to new ingredients.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of this subchapter, and annually 
                thereafter, each manufacturer shall submit to the 
                Secretary a safety assessment for each new ingredient, 
                constituent, substance, or compound that such 
                manufacturer desires to make a part of a tobacco 
                product. Such new ingredient, constituent, substance, 
                or compound shall not be included in a tobacco product 
                prior to approval by the Secretary of such a safety 
                assessment.
                    ``(B) Method of filing.--A safety assessment 
                submitted under subparagraph (A) shall be signed by an 
                officer of the manufacturer who is acting on behalf of 
                the manufacturer and who has the authority to bind the 
                manufacturer, and contain a statement that ensures that 
                the information contained in the assessment is true, 
                complete and accurate.
                    ``(C) Definition of new ingredient.--For purposes 
                of subparagraph (A), the term `new ingredient, 
                constituent, substance, or compound' means an 
                ingredient, constituent, substance, or compound listed 
                under subsection (a)(1) that was not used in the brand 
                or variety of tobacco product involved prior to January 
                1, 1998.
            ``(2) Application to other ingredients.--With respect to 
        the application of this section to ingredients, constituents, 
        substances, or compounds listed under subsection (a) to which 
        paragraph (1) does not apply, all such ingredients, 
        constituents, substances, or compounds shall be reviewed 
        through the safety assessment process within the 5-year period 
        beginning on the date of enactment of this subchapter. The 
        Secretary shall develop a procedure for the submission of 
        safety assessments of such ingredients, constituents, 
        substances, or compounds that staggers such safety assessments 
        within the 5-year period.
            ``(3) Basis of assessment.--The safety assessment of an 
        ingredient, constituent, substance, or compound described in 
        paragraphs (1) and (2) shall--
                    ``(A) be based on the best scientific evidence 
                available at the time of the submission of the 
                assessment; and
                    ``(B) demonstrate that there is a reasonable 
                certainty among experts qualified by scientific 
                training and experience who are consulted, that the 
                ingredient, constituent, substance, or compound will 
                not present any risk to consumers or the public in the 
                quantities used under the intended conditions of use.
    ``(c) Prohibition.--
            ``(1) Regulations.--Not later than 12 months after the date 
        of enactment of this subchapter, the Secretary shall promulgate 
        regulations to prohibit the use of any ingredient, constituent, 
        substance, or compound in the tobacco product of a 
        manufacturer--
                    ``(A) if no safety assessment has been submitted by 
                the manufacturer for the ingredient, constituent, 
                substance, or compound as otherwise required under this 
                section; or
                    ``(B) if the Secretary finds that the manufacturer 
                has failed to demonstrate the safety of the ingredient, 
                constituent, substance, or compound that was the 
                subject of the assessment under paragraph (2).
            ``(2) Review of assessments.--
                    ``(A) General review.--Not later than 180 days 
                after the receipt of a safety assessment under 
                subsection (b), the Secretary shall review the findings 
                contained in such assessment and approve or disapprove 
                of the safety of the ingredient, constituent, 
                substance, or compound that was the subject of the 
                assessment. The Secretary may, for good cause, extend 
                the period for such review. The Secretary shall provide 
                notice to the manufacturer of an action under this 
                subparagraph.
                    ``(B) Inaction by secretary.--If the Secretary 
                fails to act with respect to an assessment of an 
                existing ingredient, constituent, substance, or 
                additive during the period referred to in subparagraph 
                (A), the manufacturer of the tobacco product involved 
                may continue to use the ingredient, constituent, 
                substance, or compound involved until such time as the 
                Secretary makes a determination with respect to the 
                assessment.
    ``(d) Right To Know; Full Disclosure of Ingredients to the 
Public.--
            ``(1) In general.--Except as provided in paragraph (3), a 
        package of a tobacco product shall disclose all ingredients, 
        constituents, substances, or compounds contained in the product 
        in accordance with regulations promulgated unde
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r section 701(a) 
        by the Secretary.
            ``(2) Disclosure of percentage of domestic and foreign 
        tobacco.--The regulations referred to in paragraph (1) shall 
        require that the package of a tobacco product disclose, with 
        respect to the tobacco contained in the product--
                    ``(A) the percentage that is domestic tobacco; and
                    ``(B) the percentage that is foreign tobacco.
            ``(3) Health disclosure.--Notwithstanding section 301(j), 
        the Secretary may require the public disclosure of any 
        ingredient, constituent, substance, or compound contained in a 
        tobacco product that relates to a trade secret or other matter 
        referred to in section 1905 of title 18, United States Code, if 
        the Secretary determines that such disclosure will promote the 
public health.

``SEC. 575. REDUCED RISK PRODUCTS.

    ``(a) Prohibition.--
            ``(1) In general.--No manufacturer, distributor or retailer 
        of tobacco products may make any direct or implied statement in 
        advertising or on a product package that could reasonably be 
        interpreted to state or imply a reduced health risk associated 
        with a tobacco product unless the manufacturer demonstrates to 
        the Secretary, in such form as the Secretary may require, that 
        based on the best available scientific evidence the product 
        significantly reduces the overall health risk to the public 
        when compared to other tobacco products.
            ``(2) Submission to secretary.--Prior to making any 
        statement described in paragraph (1), a manufacturer, 
        distributor or retailer shall submit such statement to the 
        Secretary, who shall review such statement to ensure its 
        accuracy and, in the case of advertising, to prevent such 
        statement from increasing, or preventing the contraction of, 
        the size of the overall market for tobacco products.
    ``(b) Determination by Secretary.--If the Secretary determines that 
a statement described in subsection (a)(2) is permissible because the 
tobacco product does present a significantly reduced overall health 
risk to the public, the Secretary may permit such statement to be made.
    ``(c) Development or Acquisition of Reduced Risk Technology.--
            ``(1) In general.--Any manufacturer that develops or 
        acquires any technology that the manufacturer reasonably 
        believes will reduce the risk from tobacco products shall 
        notify the Secretary of the development or acquisition of the 
        technology. Such notice shall be in such form and within such 
        time as the Secretary shall require.
            ``(2) Confidentiality.--With respect to any technology 
        described in paragraph (1) that is in the early stages of 
        development (as determined by the Secretary), the Secretary 
        shall establish protections to ensure the confidentiality of 
        any proprietary information submitted to the Secretary under 
        this subsection during such development.

``SEC. 576. ACCESS TO COMPANY INFORMATION.

    ``(a) Compliance Procedures.--Each manufacturer of tobacco products 
shall establish procedures to ensure compliance with this Act.
    ``(b) Requirement.--In addition to any other disclosure obligations 
under this Act, the KIDS Act, or any other law, each manufacturer of 
tobacco products shall, not later than 90 days after the date of the 
enactment of the KIDS Act and thereafter as required by the Secretary, 
disclose to the Secretary all nonpublic information and research in its 
possession or control relating to the addiction or dependency, or the 
health or safety of tobacco products, including (without limitation) 
all research relating to processes to make tobacco products less 
hazardous to consumers and the research and documents described in 
subsection (c).
    ``(c) Research and Documents.--The documents described in this 
section include any documents concerning tobacco product research 
relating to--
            ``(1) nicotine, including--
                    ``(A) the interaction between nicotine and other 
                components in tobacco products including ingredients in 
                the tobacco and smoke components;
                    ``(B) the role of nicotine in product design and 
                manufacture, including product charters, and parameters 
                in product development, the tobacco blend, filter 
                technology, and paper;
                    ``(C) the role of nicotine in tobacco leaf 
                purchasing;
                    ``(D) reverse engineering activities involving 
                nicotine (such as analyzing the products of other 
                companies);
                    ``(E) an analysis of nicotine delivery; and
                    ``(F) the biology, psychopharmacology and any other 
                health effects of nicotine;
            ``(2) other ingredients, including--
                    ``(A) the identification of ingredients in tobacco 
                products and constituents in smoke, including additives 
                used in product components such as paper, filter, and 
                wrapper;
                    ``(B) any research on the health effects of 
                ingredients; and
                    ``(C) any research or other information explaining 
                what happens to ingredients when they are heated and 
                burned;
            ``(3) less hazardous or safer products, including any 
        research or product development information on activities 
        involving reduced risk, less hazardous, low-tar or reduced-tar, 
        low-nicotine or reduced-nicotine or nicotine-free products; and
            ``(4) tobacco product advertising, marketing and promotion, 
        including--
                    ``(A) documents related to the design of 
                advertising campaigns, including the desired 
                demographics for individual products on the market or 
                being tested;
                    ``(B) documents concerning the age of initiation of 
                tobacco use, general tobacco use behavior, beginning 
                smokers, pre-smokers, and new smokers;
                    ``(C) documents concerning the effects of 
                advertising; and
                    ``(D) documents concerning future marketing options 
                or plans in light of the requirements and regulations 
                to be imposed under this subchapter or the KIDS Act.
    ``(d) Authority of Secretary.--With respect to tobacco product 
manufacturers, the Secretary shall have the same access to records and 
information and inspection authority as is available with respect to 
manufacturers of other medical devices.

``SEC. 577. OVERSIGHT OF TOBACCO PRODUCT MANUFACTURING.

    ``The Secretary shall by regulation prescribe good manufacturing 
practice standards for tobacco products. Such regulations shall be 
modeled after good manufacturing practice regulations for medical 
devices, food, and other items under section 520(f). Such standards 
shall be directed specifically toward tobacco products, and shall 
include--
            ``(1) a quality control system, to ensure that tobacco 
        products comply with such standards;
            ``(2) a system for inspecting tobacco product materials to 
        ensure their compliance with such standards;
            ``(3) requirements for the proper handling of finished 
        tobacco products;
            ``(4) strict tolerances for pesticide chemical residues in 
        or on tobacco or tobacco product commodities in the possession 
        of the manufacturer, except that nothing in this paragraph 
        shall be construed to affect any authority of the Environmental 
        Protection Agency;
            ``(5) authority for officers or employees of the Secretary 
        to inspect any factory, warehouse, or other establishment of 
        any tobacco product manufa
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cturer, and to have access to 
        records, files, papers, processes, controls and facilities 
        related to tobacco product manufacturing, in accordance with 
        appropriate authority and rules promulgated under this Act; and
            ``(6) a requirement that the tobacco product manufacturer 
        maintain such files and records as the Secretary may specify, 
        as well as that the manufacturer report to the Secretary such 
        information as the Secretary shall require, in accordance with 
        section 519.

``SEC. 578. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``Notwithstanding section 521 and except as otherwise provided for 
in section 572(e), nothing in this subchapter shall be construed as 
prohibiting a State or locality from imposing requirements, 
prohibitions, penalties or other measures to further the purposes of 
this subchapter that are in addition to the requirements, prohibitions, 
or penalties required under this subchapter. State and local 
governments may impose additional tobacco product control measures to 
further restrict or limit the use of such products.''.

SEC. 113. FUNDING.

    (a) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this subtitle 
(and the amendments made by this subtitle).
    (b) Trigger.--No expenditures shall be made under this subtitle (or 
the amendments made by this subtitle) during any fiscal year in which 
the annual amount appropriated for the Food and Drug Administration is 
less than the amount so appropriated for the prior fiscal year.

SEC. 114. REPEALS.

    The following provisions of law are repealed:
            (1) The Federal Cigarette Labeling and Advertising Act (15 
        U.S.C. 1331 et seq.), except for the first section and sections 
        5(d)(1) and (2) and 6.
            (2) The Comprehensive Smokeless Tobacco Health Education 
        Act of 1986 (15 U.S.C. 4401 et seq.), except for sections 1, 
        3(f) and 8(a) and (b).
            (3) The Comprehensive Smoking Education Act of 1964 (Public 
        Law 98-474).

                   TITLE II--MISCELLANEOUS PROVISIONS

SEC. 201. NONAPPLICATION TO TOBACCO PRODUCERS.

    (a) In General.--This Act and the amendments made by this Act shall 
not apply to the producers of tobacco leaf, including tobacco growers, 
tobacco warehouses, and tobacco grower cooperatives.
    (b) Rule of Construction.--Nothing in this Act, or an amendment 
made by this Act, shall be construed to provide the Secretary of Health 
and Human Services with the authority to--
            (1) enter onto a farm owned by a producer of tobacco leaf 
        without the written consent of such producer; or
            (2) promulgate regulations on any matter that involves the 
        production of tobacco leaf or a producer thereof, other than 
        activities by a manufacturer that affect production.
    (c) Manufacturer Acting as Producer.--Notwithstanding any other 
provision of this section, if a producer of tobacco leaf is also a 
tobacco product manufacturer or is owned or controlled by a tobacco 
product manufacturer, the producer shall be subject to the provisions 
of this Act, and the amendments made by this Act, in the producer's 
capacity as a manufacturer.
    (d) Definition.--In this section, the term ``controlled by'' means 
a producer that is a member of the same controlled group of 
corporations, as that term is used for purposes of section 52(a) of the 
Internal Revenue Code of 1986, or under common control within the 
meaning of the regulations promulgated under section 52(b) of such 
Code.

SEC. 202. EQUAL TREATMENT OF RETAIL OUTLETS.

    The Secretary of Health and Human Services shall promulgate 
regulations to require that retail establishments that are accessible 
to individuals under the age of 18, for which the predominant business 
is the sale of tobacco products, comply with any advertising 
restrictions applicable to such establishments.
                                 &lt;all&gt;

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