[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4042 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 4042

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
     jurisdiction of the Food and Drug Administration over tobacco.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 21, 2000

   Mr. Waxman (for himself, Mr. Meehan, Mr. Doggett, Mr. Markey, Ms. 
    DeLauro, Mr. Stark, Ms. Slaughter, Mr. Weygand, and Mr. Allen) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
     jurisdiction of the Food and Drug Administration over 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 ``FDA Tobacco Jurisdiction Act of 
2000''.

SEC. 2. 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 (21 U.S.C. 301 et 
seq.).

SEC. 3. DEFINITIONS.

    (a) 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)''.
    (b) 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.''.
    (c) 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.''.

SEC. 4. AMENDMENTS TO CHAPTER V.

    (a) Misbranding.--Section 502 (21 U.S.C. 360) is amended by adding 
at the end the following:
    ``(u) In the case of a tobacco product, if it does not comply with 
a requirement under subchapter F.''.
    (b) Clarification of Authority.--Section 520(e) (21 U.S.C. 360j(e)) 
is amended by adding at the end the following:
    ``(3) In the case of tobacco products, the restrictions on sale and 
distribution authorized by paragraph (1) shall include restrictions on 
advertising and promotion of tobacco products.''.
    (c) Preemption.--Section 521(a) (21 U.S.C. 360k(a)) is amended--
            (1) by striking ``Except as provided in subsection (b)'' 
        and inserting ``Except in the case of tobacco products and as 
        provided in subsection (b)''; and
            (2) by adding at the end the following:

                           ``tobacco products

    ``(c) If the package or advertisement of a tobacco product is 
required to bear a warning under this Act, no statement relating to the 
use of the tobacco product and health, other than a statement required 
under this Act, may be required by any State or local statute or 
regulation to be included on any package or in any advertisement of 
such tobacco product.''.

SEC. 5. VALIDATION OF THE FDA RULE.

    (a) In General.--All provisions of the regulations related to 
tobacco products promulgated by the Secretary of Health and Human 
Services on August 28, 1996 (61 Fed. Reg. 44396) shall be considered to 
be lawful, and to have been lawfully promulgated, under the Federal 
Food, Drug, and Cosmetic Act.
    (b) Effective Date.--Provisions of such regulations which are not 
in effect on the date of the enactment of this Act shall take effect 
upon the expiration of 9 months after such date.

SEC. 6. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.

    Chapter V is amended by adding at the end the following:

        ``Subchapter F--Special Provisions for Tobacco Products

``SEC. 565. SPECIAL STANDARD FOR TOBACCO PRODUCTS.

    ``In the case of tobacco products, an action that provides 
appropriate protection of public health shall be deemed to provide a 
reasonable assurance of safety and effectiveness.

``SEC. 566. 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.--
            ``(1) Cigarettes and smokeless tobacco.--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.
            ``(2) Prohibition.--It shall be unlawful to advertise 
        tobacco products on any medium of electronic communication 
        subject to the jurisdiction of the Federal Communications 
        Commission.
    ``(c) Ingredients.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of this subchapter, the Secretary shall promulgate 
        regulations relating to ingredients in tobacco products. Except 
        as provided in paragraph (2), such regulations shall conform 
to the specifications described in Title IF of the Proposed Resolution 
entered into by the tobacco manufacturers and the State attorneys 
general on June 20, 1997.
            ``(2) Failure to act.--If the Secretary fails to approve or 
        disapprove an ingredient's safety within the review period 
        prescribed under the regulations under paragraph (1), such 
        failure shall not be considered an approval of such ingredient.
    ``(d) Reduced-Risk Products.--No manufacturer of a tobacco product 
may state or imply in the labeling or advertisements of the tobacco 
product that the tobacco product presents a reduced risk to health 
unless the Secretary has determined that the tobacco product does 
present a significantly reduced risk to health.
    ``(e) Other Authority.--This section does not limit the authority 
the Secretary has under other provisions of this Act with respect to 
tobacco products.

``SEC. 567. STATE TOBACCO CONTROL PROGRAMS.

    ``(a) In General.--Effective 2 years after the date of the 
enactment of this subchapter, a State may not receive funds under this 
Act for tobacco control activities unless the State has put into law a 
State tobacco control program that conforms to the model State program 
established by the Secretary under subsection (b).
    ``(b) Model State Program.--
            ``(1) General rule.--Within one year of the date of the 
        enactment of this subchapter, the Secretary shall establish a 
        model State tobacco control program.
            ``(2) Program content.--The model State tobacco control 
        program established under paragraph (1) shall--
                    ``(A) require persons who sell tobacco products to 
                individuals for personal consumption to obtain a 
                license from the State;
                    ``(B) require licensed retailers to comply with the 
                requirements under this Act that are applicable to 
                tobacco product retailers;
                    ``(C) prohibit any individual from purchasing 
                tobacco products for resale or distribution to 
                individuals under the age of 18;
                    ``(D) include minimum requirements for the conduct 
                and frequency of compliance inspections of licensed 
                retailers;
                    ``(E) include State performance objectives, 
                including objectives for reducing the level of 
                violations observed during compliance inspections;
                    ``(F) include provisions for appropriate penalties 
                for violations of the program requirements, including 
                provisions for license suspension and revocation; and
                    ``(G) include such other provisions as the 
                Secretary determines are appropriate to protect public 
                health.
    ``(c) Failure To Implement.--If a State fails to effectively 
implement a State tobacco control program which conforms to the Model 
State program established under subsection (b) or if a State fails to 
achieve the performance objectives applicable to the State under the 
Model State program, the Secretary shall withhold up to 20 percent of 
the funds made available under this Act to the State for tobacco 
control activities.
    ``(d) Federal Licensing Program.--Within one year of the date of 
the enactment of this subchapter, the Secretary shall establish Federal 
licensing requirements for--
            ``(1) tobacco product retailers operating on Federal 
        property;
            ``(2) tobacco product retailers operating in a State which 
        does not put into law or effectively implement a State tobacco 
        control program which conforms to the Model State Program; and
            ``(3) such other tobacco product retailers as the Secretary 
        may specify.
The Federal tobacco control requirements shall conform to the licensing 
requirements of the Model State Program.
    ``(e) Federal Authority.--The Secretary may order a retailer 
licensed by a State to suspend or cease selling tobacco products if the 
tobacco product retailer is in violation of a requirement under this 
Act related to tobacco products.
    ``(f) Indian Tribes.--In the case of tobacco product retailers 
operating on Indian reservations, the governing Indian tribe or tribal 
organization shall be treated as a State.''.

SEC. 7. GENERAL PROVISIONS.

    (a) Enforcement.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
    ``(aa) The violation of any requirement under this Act relating to 
tobacco products.''.
    (b) Access to Information.--Section 701 (21 U.S.C 371) is amended 
by adding at the end the following:
    ``(h) To acquire information related to tobacco products, the 
Secretary may administer oaths and require the testimony of witnesses 
and the production of documents and other materials. The Secretary may 
disclose to the public information acquired under this subsection if 
the Secretary determines that disclosure is appropriate to protect 
public health.''.

SEC. 8. REPEAL.

    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.) are repealed on the date the 
regulations described in section 566(b) of the Federal Food, Drug, and 
Cosmetic Act take effect.
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