[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 672 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 672

To amend the Federal Food, Drug, and Cosmetic Act to regulate the sale 
    and distribution of tobacco products containing tar, nicotine, 
additives, carbon monoxide, and other potentially harmful constituents, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               March 30 (legislative day, March 3), 1993

   Mr. Bingaman (for himself, Mr. Chafee, Mr. Bradley, and Mr. Pell) 
introduced the following bill; which was read twice and referred to the 
           Committee on Commerce, Science, and Transportation

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to regulate the sale 
    and distribution of tobacco products containing tar, nicotine, 
additives, carbon monoxide, and other potentially harmful constituents, 
                        and for other purposes.

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

SECTION 1. SHORT TITLE; REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Tobacco Health and 
Safety Act''.
    (b) Reference.--Whenever in this Act 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.

SEC. 2. FINDINGS.

    The Congress finds that--
            (1) cigarette smoking and the use of smokeless tobacco 
        products continue to represent a major health hazard to the 
        American public,
            (2) cigarette smoking continues to be the single most 
        preventable cause of death and disability in the United States,
            (3) tobacco products contain hazardous tobacco additives, 
        gases, and other chemical constituents dangerous to health,
            (4) the use of tobacco products cost the United States in 
        excess of $60,000,000,000 in lost productivity and health care 
        costs,
            (5) tobacco products contain nicotine, a poisonous 
        addictive drug,
            (6) the tobacco industry has maintained that smoking is an 
        adult practice and that smoking and the use of smokeless 
        tobacco is not a practice to be carried out by young people,
            (7) 60 percent of all new smokers are under the age of 14 
        years of age,
            (8) despite the known adverse health effects associated 
        with tobacco, it remains one of the least regulated consumer 
        products,
            (9) in one year alone, 1990, the tobacco industry spent 
        more than $4,000,000,000 to promote and sell its products,
            (10) the Congress of the United States has a major policy-
        setting role in ensuring that the use of tobacco products is 
        discouraged to the maximum extent possible, and
            (11) creation of a separate chapter for tobacco under the 
        Federal Food, Drug, and Cosmetic Act assures the most effective 
        means of regulating the product without the product being 
        banned.

SEC. 3. DEFINITIONS.

    Section 201 (21 U.S.C. 321) is amended by adding at the end thereof 
the following new paragraphs:
    ``(bb) The term `tobacco product' means cigarettes, cigars, little 
cigars, pipe tobacco, smokeless tobacco, snuff, and chewing tobacco.
    ``(cc) The term `tobacco additive' means any substance the intended 
use of which results or may reasonably be expected to result, directly 
or indirectly, in its becoming a component or otherwise affecting the 
characteristics of any tobacco product.
    ``(dd) The term `constituent' means any element of cigarette 
mainstream or sidestream smoke which is present in quantities which 
represent a potential health hazard or where health effect is unknown.
    ``(ee) The term `tar' means mainstream total articulate matter 
minus nicotine and water.''.

SEC. 4. ENFORCEMENT.

    Section 301 (21 U.S.C. 331) is amended by adding at the end thereof 
the following new subsection:
    ``(t) The sale or distribution of tobacco products in violation of 
section 701 and the manufacture, importation, or packaging of tobacco 
products in violation of section 705.''.

SEC. 5. REGULATION.

    (a) Regulation.--The Federal Food, Drug, and Cosmetic Act is 
amended by redesignating chapters VII, VIII, and IX as chapters VIII, 
IX, and X, respectively, and by adding after chapter VI the following:

                    ``CHAPTER VII--TOBACCO PRODUCTS

                           ``prohibited acts

    ``Sec. 701. (a) It shall be unlawful for a tobacco product intended 
for use by man which contains nicotine or tobacco additives or, because 
of its pharmacological and toxicological effects or other potentiality 
for harmful effects, presents risks to health--
            ``(1) to be sold to any person under the age of 18 years or 
        under such other age, greater than 18, as the State in which 
        the sale occurs may by law establish,
            ``(2) to be distributed if the product is misbranded as 
        prescribed by section 702,
            ``(3) to be distributed if the product is adulterated as 
        prescribed by section 703, or
            ``(4) to be distributed as a free sample or to be made 
        available as the result of coupons or other materials which 
        allow for the obtaining of free or discounted tobacco products.
    ``(b)(1) In carrying out the requirements of subsection (a)(1), 
States shall enact such laws and promulgate such regulations as may be 
necessary to ensure compliance.
    ``(2) If the Secretary finds that--
            ``(A) the implementation and enforcement of State laws and 
        regulations is insufficient to require compliance with the 
        requirement of subsection (a)(1), and
            ``(B) Federal regulation will provide the only reasonable 
        assurance of the inaccessibility of tobacco products to those 
        who are lawfully prohibited from purchasing such products, the 
        Secretary may, to assist in enforcing such requirement, by 
        regulation impose requirements on the form, manner, or location 
        of the sale of tobacco products in such State or on any 
        combination of such aspects of the sale of tobacco products. A 
        tobacco product which is sold or distributed in violation of 
        subsection (a)(1) or (a)(4) shall be considered a misbranded 
        tobacco product.

                     ``misbranded tobacco products

    ``Sec. 702. (a) A tobacco product shall be deemed to be 
misbranded--
            ``(1) if its labeling is false or misleading in any 
        particular,
            ``(2) if the labeling fails to contain the statements 
        required by section 4 of the Cigarette Labeling and Advertising 
        Act (15 U.S.C. 1333) and the Comprehensive Smokeless Tobacco 
        Health Education Act (15 U.S.C. 4401 et. seq.),
            ``(3) if the labeling fails to contain the statement 
        `Federal Law Prohibits Sale to Minors' in a prominent and 
        conspicuous place as prescribed by regulation by the Secretary,
            ``(4) if in package form, unless it bears a label 
        containing--
                    ``(A) the name and place of business of the 
                manufacturer, packer, or distributor, and
                    ``(B) an accurate statement of the quantity of the 
                contents in terms of weight, measure, or numerical 
                count,
        except that under regulations of the Secretary reasonable 
        variations from the requirements of this paragraph shall be 
        permitted and exemptions from such requirements for small 
        packages shall be established,
            ``(5) if the manufacturer, importer, or packager of the 
        product does not provide the list of tobacco additives 
        contained in the product in accordance with section 704(a),
            ``(6) if it does not disclose the tobacco additives 
        contained in the product as required under section 704(b), or
            ``(7) if it does not disclose tar, nicotine, carbon 
        monoxide, and other constituents as required under section 705.
    ``(b) The Secretary may by regulation require that the manufacturer 
of tobacco products provide consumers of tobacco products with 
additional information, by way of additional labeling of packages, 
requiring inserts or other means, about the adverse effects of tobacco 
products, adequate warnings and directions for use, contraindications, 
adequate warnings against use in pathological conditions, and any 
information deemed necessary by the Secretary.
    ``(c)(1) Nothing in this chapter or the Federal Cigarette Labeling 
and Advertising Act (15 U.S.C. 1333 et seq.) shall prohibit a 
manufacturer of tobacco products from providing consumers with 
information about the adverse effects of tobacco products in addition 
to the information they are required to provide pursuant to this 
chapter and the Federal Cigarette Labeling and Advertising Act (15 
U.S.C. 1333 et seq.).
    ``(2) The Secretary shall have the authority to modify existing 
warning labels as required by the Federal Cigarette Labeling and 
Advertising Act and the Comprehensive Smokeless Tobacco Health 
Education Act so long as such modifications do not weaken the health 
message contained in such warnings.

                     ``adulterated tobacco products

    ``Sec. 703. A tobacco product shall be deemed to be adulterated--
            ``(1) if the level of any tobacco additive contained in the 
        product is in violation of a requirement under section 704(b),
            ``(2) if the nicotine, tar, carbon monoxide, or other 
        harmful constituent level has not been established under 
        section 705,
            ``(3) if it bears or contains any added poisonous or 
        deleterious substance which may render it injurious to health,
            ``(4) if it contains in whole or in part any filthy, 
        putrid, or decomposed substance,
            ``(5) if it has been prepared, packed, or held under 
        unsanitary conditions whereby it may have become contaminated 
        with filth or whereby it may have been rendered injurious to 
        health, or
            ``(6) if its container or packaging is composed in whole or 
        in part of any poisonous or deleterious substance which may 
        render the contents injurious to health.

                          ``tobacco additives

    ``Sec. 704. (a) It shall be unlawful for any person to manufacture, 
import, or package for sale or distribution within the United States 
any tobacco product unless such person has provided to the Secretary a 
complete list of each tobacco additive used in the manufacture of such 
tobacco product and the relative quantity of such additive.
    ``(b)(1) The Secretary shall by regulation prescribe any disclosure 
requirements on packages of tobacco products or by any other means in 
order to adequately inform the public of the tobacco additives 
contained in tobacco products.
    ``(2) If the Secretary determines that any tobacco additive in a 
tobacco product, either by itself or in conjunction with any other 
additive, is unsafe and presents unnecessary increased risks to health, 
the Secretary may require that such levels of the tobacco additive in 
the tobacco product be reduced or that it be prohibited from use. The 
Secretary may make such a determination only with the advice of experts 
qualified by scientific training and experience to evaluate the safety 
of tobacco additives.

        ``nicotine, tar, carbon monoxide, and other constituents

    ``Sec. 705. (a) It shall be unlawful for any person to manufacture, 
import, or package for sale or distribution within the United States 
any tobacco product unless such person has provided the Secretary with 
a complete list of all brands of such tobacco products and until such 
products have been tested by the Secretary to establish the tar, 
nicotine, carbon monoxide, and other constituent (as determined by the 
Secretary) levels for each brand.
    ``(b) The Secretary may by regulation prescribe any disclosure 
requirements on packages of tobacco products or by any other means to 
adequately inform the public of the quantities and levels of nicotine, 
tar, carbon monoxide, or other constituents and initiate and carry out 
any educational activities to adequately inform the public that any 
reduced levels of nicotine, tar, carbon monoxide, or other constituents 
do not necessarily constitute a reduced health risk.

                               ``reports

    ``Sec. 706. The Secretary shall report annually to the Committee on 
Energy and Commerce of the House of Representatives and the Committee 
on Labor and Human Resources of the Senate on--
            ``(1) the use of tobacco additives in tobacco products, 
        including a list of tobacco additives which have been 
        prohibited from use in tobacco products,
            ``(2) the levels of nicotine, tar, carbon monoxide, and 
        other potentially harmful constituents in tobacco products or 
        tobacco smoke and any actions the Secretary has taken to reduce 
        the levels of these constituents, and
            ``(3) any legislative recommendations that would further 
        reduce the risk to health associated with the use of tobacco 
        products, tobacco additives, nicotine, tar, or other 
        potentially harmful constituents.''.
    (b) Conforming Amendments.--Sections 701 through 709 are 
redesignated as sections 801 through 809, respectively, sections 801 
and 802 are redesignated as sections 901 and 902, respectively, and 
sections 901 and 902 are redesignated as sections 1001 and 1002, 
respectively.

SEC. 6. WARNING LABELS.

    Section 4(a) of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333(a)) is amended by striking out in paragraphs (1), (2), 
and (3) the phrase ``surgeon general's warning: Cigarette Smoke 
Contains Carbon Monoxide,'' and inserting in lieu thereof the 
following: ``surgeon general's warning: Smoking is Addictive. Once you 
start you may not be able to stop.''

SEC. 7. NONTOBACCO NICOTINE CONTAINING PRODUCTS.

    Any product which contains nicotine but does not meet the 
definition of tobacco products as contained in section 201(bb) of the 
Federal Food, Drug, and Cosmetic Act shall be deemed to be a drug under 
section 201(g)(1)(C) of such Act.

SEC. 8. MISCELLANEOUS.

    (a) Construction.--Nothing in the amendment made by section 5 shall 
supersede, repeal, or modify any requirement of the Federal Cigarette 
Labeling and Advertising Act (15 U.S.C. 1333), and the Comprehensive 
Smokeless Tobacco Health Education Act (15 U.S.C. 4401 et. seq.).
    (b) Effective Date.--The amendments made by this Act shall be 
effective 6 months after date of enactment.

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