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

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    ``(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:
    ``(bb) 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.

Summary: FDA Tobacco Jurisdiction Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to give the Food and Drug Administration (FDA) jurisdiction over tobacco products as drugs or devices. Declares lawful a specified Federal regulation regarding tobacco. Deems, for tobacco, an action providing appropriate protection of public health to provide a reasonable assurance of safety and effectiveness. Mandates additional restrictions on marketing, advertising, and access. Provides for model State tobacco control programs. Repeals the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act of 1986.