[Congressional Record Volume 147, Number 16 (Tuesday, February 6, 2001)]
[Senate]
[Pages S1063-S1066]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself, Mr. L. Chafee, Mr. Graham, Mr. 
        Bingaman, and Mr. Johnson):
  S. 247. A bill to provide for the protection of children from 
tobacco; to the Committee on Health, Education, Labor, and Pensions.
  Mr. HARKIN. Mr. President, just under 3 years ago, on March 31, 1998, 
Senators Harkin, John Chafee and Graham teamed up to introduce the 
first comprehensive bipartisan legislation to reduce teen smoking. 
Today, I am pleased to announce that Senators Harkin, Lincoln Chafee 
and Graham are teaming up again with the same goal. We are re-
introducing the first bipartisan Senate bill to restore the Food and 
Drug Administration's authority to protect our kids from tobacco.
  We hope the introduction of this bill is the beginning of a 
bipartisan push to get this type of common sense legislation passed. 
The need is clear. As Supreme Court Justice Sandra Day O'Connor 
recognized, tobacco use among children and adolescents is probably the 
single most significant threat to public health in the United States. 
Study after study has shown how the tobacco industry continues to 
successfully target our children. In a survey done by the Campaign for 
Tobacco Free Kids, seventy-three percent of teens reported seeing 
tobacco advertising in the previous two weeks, compared to only 33 
percent of adults. And 77 percent of teens say it is easy for kids to 
buy cigarettes.
  This is why every day another 3000 kids in this country become 
regular smokers. And that is why cigarette smoking among high school 
seniors is at a 19-year high.
  There is no question. Nicotine is an addictive product and cigarettes 
kill. Even the tobacco companies are starting to admit it. In fact, Big 
Tobacco has known this for so long, they deliberately manipulate the 
nicotine in cigarettes to get more people addicted.
  The FDA regulations, struck down by the Supreme Court last year, were 
about stopping kids from smoking. These regulations were an investment 
in the future of our kids. They also provided consumers with critical 
protections against false advertising and health claims by tobacco 
manufacturers.
  Tobacco companies are making harm reduction claims about new products 
with no real independent examination or oversight. This deceptive, 
self-interested behavior is not part of a new pattern. The history of 
tobacco companies is rife with examples of deceptive practices designed 
to addict both adults and children with their harmful products. Our 
bill will ensure that this type of behavior is stopped.
  Our legislation re-affirms the FDA's authority over tobacco products. 
It classifies nicotine as a drug and tobacco products as drug delivery 
devices. It allows FDA to implement a ``public health'' standard in its 
review and regulation of tobacco products. Companies will be prevented 
from making claims of reduced risk unless they can show scientific 
evidence their product is actually safer.
  By codifying FDA's regulation of 1996, our legislation also allows 
for continuation of the critically important youth ID checks. It 
provides needed youth access restrictions such as requiring tobacco 
products to be kept behind store counters and ban vending machines. It 
also includes sensible advertising limits to reduce teen access to 
tobacco.
  I urge my colleagues to join us in supporting this legislation. I 
hope we can work with Senators on both sides of the aisle to move this 
important issue forward.
  Mr. President, I ask unanimous consent that the text of this bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 247

       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.

[[Page S1064]]

     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, 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

[[Page S1065]]

     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, 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 under 
     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.

[[Page S1066]]

       ``(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 manufacturer, 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.
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