[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2333 Introduced in Senate (IS)]







106th CONGRESS
  2d Session
                                S. 2333

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 30, 2000

Mr. Reed (for himself and Mr. Bingaman) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to grant the Food and 
 Drug Administration the authority to regulate the manufacture, sale, 
  and distribution of tobacco and other products containing nicotine, 
  tar, additives, 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.

    This Act may be cited as the ``Tobacco Regulatory Fairness Act of 
2000''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Cigarette smoking and tobacco use cause approximately 
        450,000 deaths each year in the United States.
            (2) Cigarette smoking accounts for approximately 
        $65,000,000,000 in lost productivity and health care costs.
            (3) In spite of the well-established dangers of cigarette 
        smoking and tobacco use, there is no Federal agency that has 
        any authority to regulate the manufacture, sale, distribution, 
        and use of tobacco products.
            (4) The tobacco industry spends approximately 
        $4,000,000,000 each year to promote tobacco products.
            (5) Each day 3,000 children try cigarettes for the first 
        time, many of whom become lifelong addicted smokers.
            (6) There is no minimum age requirement in Federal law that 
        an individual must reach to legally buy cigarettes and other 
        tobacco products.
            (7) The Food and Drug Administration is the most qualified 
        Federal agency to regulate tobacco products.
            (8) It is inconsistent for the Food and Drug Administration 
        to regulate the manufacture, sale, and distribution of other 
        nicotine-containing products used as substitutes for cigarette 
        smoking and tobacco use and not be able to regulate tobacco 
        products in a comparable manner.

SEC. 3. DEFINITIONS.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(kk) The term `tobacco product' means cigarettes, cigars, little 
cigars, pipe tobacco, smokeless tobacco, snuff, and chewing tobacco.
    ``(ll) 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.
    ``(mm) 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 the health effect is 
unknown.
    ``(nn) The term `tar' means mainstream total articulate matter 
minus nicotine and water.''.

SEC. 4. ENFORCEMENT.

    Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended--
            (1) in subsections (a), (b), (c), (g), and (k), by striking 
        ``or cosmetic'' and inserting ``cosmetic, or tobacco product''; 
        and
            (2) by adding at the end the following:
    ``(u) The manufacture, sale, distribution, and advertising of 
tobacco products in violation of regulations promulgated by the 
Secretary pursuant to chapter X.''.

SEC. 5. REGULATION OF TOBACCO PRODUCTS.

    The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is 
amended by adding at the end the following:

                     ``CHAPTER X--TOBACCO PRODUCTS

``SEC. 1000. REGULATION OF TOBACCO PRODUCTS.

    ``(a) Regulations.--Not later than 1 year after the date on which 
the Secretary receives the recommendations described in section 
1003(f), the Secretary shall promulgate regulations governing the 
manufacture, sale, and distribution of tobacco products in accordance 
with the provisions of the chapter.
    ``(b) Food and Drug Administration.--Regulations promulgated under 
subsection (a) shall designate the Food and Drug Administration as the 
Federal agency that regulates the manufacture, distribution, and sale 
of tobacco products.
    ``(c) Limitation.--Regulations promulgated under subsection (a) may 
not prohibit the manufacture, distribution, or sale of a tobacco 
product solely on the basis that such product causes a disease.
    ``(d) Sale or Distribution.--Under regulations promulgated under 
subsection (a) it shall be unlawful to--
            ``(1) sell a tobacco product to an individual under the age 
        of 18 years;
            ``(2) sell a tobacco product to an individual if such 
        tobacco product is intended for use by an individual under the 
        age of 18 years; and
            ``(3) sell or distribute a tobacco product if the label of 
        such product does not display the following statement: `Federal 
        Law Prohibits Sale To Minors'.
    ``(e) Manufacturing.--Regulations promulgated under subsection (a) 
governing the manufacture of tobacco products shall--
            ``(1) require that all additives used in the manufacture of 
        tobacco products are safe; and
            ``(2) classify as a drug any nicotine-containing product 
        that does not meet the definition of a tobacco product.

``SEC. 1001. ADULTERATED TOBACCO PRODUCTS.

    ``(a) In General.--A tobacco product shall be deemed to be 
adulterated--
            ``(1) if such product consists in whole or in part of any 
        filthy, putrid, or decomposed substance, or is otherwise 
        contaminated by any poisonous or deleterious substance that may 
        render such product injurious to health;
            ``(2) if such product has been prepared, packed, or held 
        under insanitary conditions in which such product may have been 
        contaminated with filth, or in which such product may have been 
        rendered injurious to health; and
            ``(3) if the container for such product is composed, in 
        whole or in part, of any poisonous or deleterious substance 
        that may render the contents of such product injurious to 
        health.
    ``(b) Regulations.--The Secretary may by regulation prescribe good 
manufacturing practices for tobacco products. Such regulations may be 
modeled after current good manufacturing practice regulations for other 
products regulated under this Act.

``SEC. 1002. MISBRANDED TOBACCO PRODUCTS.

    ``A tobacco product shall be deemed to be misbranded--
            ``(1) if the labeling of such product is false or 
        misleading in any particular;
            ``(2) if in package form unless such product bears a label 
        containing--
                    ``(A) the name and place of business of the tobacco 
                product 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 subparagraph (B) of this paragraph reasonable 
        variations shall be permitted, and exemptions as to small 
        packages shall be established, by regulations promulgated by 
        the Secretary;
            ``(3) if any word, statement, or other information required 
        by or under authority of this chapter to appear on the label or 
        labeling is not prominently placed thereon with such 
        conspicuousness (as compared with other words, statements or 
        designs in the labeling) and in such terms as to render it 
        likely to be read and understood by the ordinary individual 
        under customary conditions of purchase and use;
            ``(4) if such product has an established name, unless its 
        label bears, to the exclusion of any other nonproprietary name, 
        its established name is prominently printed in type as required 
        by the Secretary by regulation;
            ``(5) if the Secretary has issued regulations requiring 
        that the labeling of such product bear adequate directions for 
        use, or adequate warnings against use by children, that are 
        necessary for the protection of users unless the labeling of 
        such product conforms in all respects to such regulations; and
            ``(6) if such product was manufactured, prepared, 
        propagated, or processed in an establishment not duly 
        registered as required under section 1004.

``SEC. 1003. ADVISORY COMMITTEE.

    ``(a) Establishment.--There is established in the Food and Drug 
Administration a Tobacco and Nicotine Products Advisory Committee 
(hereafter referred to as the `advisory committee').
    ``(b) Purpose.--The advisory committee shall assist the Secretary 
in developing the regulations described in section 1000.
    ``(c) Membership.--
            ``(1) In general.--Not later than 60 days after the date of 
        enactment of this chapter, the Secretary shall appoint to the 
        advisory committee 10 individuals who are qualified by training 
        and experience to evaluate and make recommendations regarding 
        regulations governing the manufacture, distribution, sale, 
        labeling and advertising of tobacco products.
            ``(2) Experts.--The members described under paragraph (1), 
        not including the chairperson of such advisory committee, shall 
        consist of--
                    ``(A) one expert in the field of nicotine 
                addiction;
                    ``(B) one expert in the field of pharmacology;
                    ``(C) one expert in the field of food and drug law;
                    ``(D) one expert in the field of public education;
                    ``(E) one expert in the field of toxicology;
                    ``(F) two experts representing the interests of 
                family medicine, internal medicine, or pediatrics; and
                    ``(G) two consumer representatives from the public 
                health community.
            ``(3) Ex officio.--The advisory committee shall have the 
        following as ex officio members:
                    ``(A) The Director of the National Cancer 
                Institute.
                    ``(B) The Director of the National Heart, Lung, and 
                Blood Institute.
                    ``(C) The Director of National Institute on Drug 
                Abuse.
                    ``(D) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(E) The Surgeon General of the Public Health 
                Service.
            ``(4) Chairperson.--The chairperson of the advisory 
        committee shall be appointed by the Secretary with the advice 
        and consent of the Commissioner of Food and Drugs.
    ``(d) Function.--The advisory committee shall--
            ``(1) review the available scientific evidence on the 
        effects of tobacco products on human health;
            ``(2) review the manufacturing process of tobacco products, 
        including the use of additives, sprayed on chemicals, product 
        development, and product manipulation;
            ``(3) review the role of nicotine as part of the smoking 
        habit, including its addictive properties and health effects; 
        and
            ``(4) review current Federal, State, and local laws 
        governing the manufacture, distribution, sale, labeling and 
        advertising of tobacco products.
    ``(e) Authority.--The advisory committee may hold hearings and 
receive testimony and evidence as the committee determines to be 
appropriate.
    ``(f) Recommendations.--Not later than 1 year after the Secretary 
has appointed all members to the advisory committee, such committee 
shall prepare and submit recommendations regarding regulations to be 
promulgated under section 1000 to the Secretary.

``SEC. 1004. REGISTRATION.

    ``Not later than 120 days after the date of enactment of this 
chapter, any manufacturer directly or indirectly engaged in the 
manufacture, distribution, or sale of tobacco products shall register 
with the Secretary the name and place of business of such manufacturer.

``SEC. 1005. ADVERTISING.

    ``(a) Regulations.--The Federal Trade Commission, after 
consultation with the Secretary and upon receipt of approval by the 
Secretary, shall promulgate regulations governing the advertising of 
all tobacco products.
    ``(b) Labels.--The Federal Trade Commission, after consultation 
with the Secretary and upon receipt of approval by the Secretary, may 
promulgate regulations that--
            ``(1) modify the warning labels required by the Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et seq.) 
        and the Comprehensive Smokeless Tobacco Health Education Act of 
        1986 (15 U.S.C. 4401 et seq.) if the modification in the 
        content of the label does not weaken the health message 
        contained in the label and is in the best interests of the 
        public health as determined by the Secretary; and
            ``(2) increase the size and placement of such required 
        labels.''.

SEC. 6. CONFORMING AMENDMENTS.

    (a) Records.--Section 703 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 373) is amended--
            (1) by striking ``or cosmetics'' each place it appears and 
        inserting ``cosmetics, or tobacco products''; and
            (2) by striking ``or cosmetic'' each place it appears and 
        inserting ``cosmetic, or tobacco product''.
    (b) Factory Inspections.--Section 704 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374) is amended--
            (1) in subsection (a)(1)--
                    (A) by striking ``or cosmetics'' each place it 
                appears and inserting ``cosmetics, or tobacco 
                products''; and
                    (B) by striking ``or restricted devices'' each 
                place it appears and inserting ``restricted devices, or 
                tobacco products''; and
            (2) in subsection (b), by striking ``or cosmetic'' and 
        inserting ``cosmetic, or tobacco product''.
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