[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1097 Introduced in House (IH)]







107th CONGRESS
  1st Session
                                H. R. 1097

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
               tobacco products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 20, 2001

  Mr. Ganske (for himself, Mr. Dingell, Mr. Baldacci, Mr. Bartlett of 
  Maryland, Mr. Bereuter, Mr. Blumenauer, Mrs. Bono, Mrs. Capps, Mr. 
DeFazio, Ms. DeGette, Mr. Doggett, Ms. Eshoo, Mr. Evans, Mr. Frank, Mr. 
Gallegly, Mr. Gilman, Mr. Green of Texas, Mr. Hansen, Mr. Hinchey, Mr. 
 Horn, Ms. Kaptur, Mr. Kind, Mr. Kucinich, Mr. LaFalce, Mr. Leach, Mr. 
  Lipinski, Mr. Luther, Mrs. Maloney of New York, Mr. McDermott, Mr. 
McGovern, Mr. Meehan, Mr. Moran of Virginia, Mrs. Morella, Mr. Nadler, 
 Mr. Nethercutt, Mr. Olver, Mr. Pallone, Mr. Payne, Ms. Roybal-Allard, 
 Ms. Schakowsky, Mr. Snyder, Mr. Stark, Mr. Stupak, Mrs. Tauscher, Mr. 
  Thompson of California, Mr. Udall of New Mexico, Mr. Underwood, Mr. 
  Waxman, Mr. Weiner, and Mr. Weller) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
               tobacco products, 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 ``FDA Tobacco Authority Amendments 
Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Tobacco products are addictive.
            (2) Such products cause over 400,000 deaths each year in 
        the United States.
            (3) The Supreme Court has held that there is no 
        congressional intent to provide the Food and Drug 
        Administration with the authority to regulate tobacco products.
            (4) The Congress should amend the Federal Food, Drug, and 
        Cosmetic Act to provide the Food and Drug Administration with 
        the authority to regulate tobacco products.

SEC. 3. DEFINITIONS.

    (a) Drug.--Section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1)) is amended by inserting after the 
first sentence the following: ``Such term includes nicotine in a 
tobacco product.''.
    (b) Devices.--Section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (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 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 any product made or derived 
from tobacco that is intended for human consumption.''.

SEC. 4. AMENDMENTS TO CHAPTER V.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (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 Regarding Advertising and Promotion; 
Equal Treatment of Retail Outlets.--Section 520(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(e)) is amended by adding at the 
end the following:
    ``(3) In the case of tobacco products:
            ``(A) The restrictions on sale and distribution authorized 
        by paragraph (1) shall include restrictions on advertising and 
        promotion of tobacco products.
            ``(B) The Secretary shall ensure that such restrictions are 
        applied uniformly to all entities that make retail sales of 
        tobacco products. For purposes of the preceding sentence, such 
        restrictions may not exempt or apply differently to retail 
        establishments that predominantly or exclusively sell tobacco 
        products.''.
    (c) Preemption.--Section 521 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360k) is amended--
            (1) in subsection (a), 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. SPECIAL PROVISIONS FOR TOBACCO PRODUCTS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) 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 is appropriate 
for the protection of public health shall be deemed to provide a 
reasonable assurance of safety and effectiveness.

``SEC. 566. WARNINGS REGARDING CIGARETTES AND SMOKELESS TOBACCO; 
              REGULATIONS.

    ``(a) In General.--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.
    ``(b) 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 public health.
    ``(c) Savings Provision.--Subsection (a) or (b) may not be 
construed as limiting the authority provided under other provisions of 
this Act with respect to tobacco products.

``SEC. 567. RULE OF CONSTRUCTION REGARDING FARMERS AND RELATED 
              ENTITIES.

    ``The provisions of this Act relating to tobacco products shall not 
apply to tobacco leaf that is not in the possession of the 
manufacturer, or to the producers of tobacco leaf, including tobacco 
growers, tobacco warehouses, and tobacco grower cooperatives, nor shall 
any employee of the Food and Drug Administration have any authority 
whatsoever to enter onto a farm owned by a producer of tobacco leaf 
without the written consent of such producer. Notwithstanding any other 
provision of this subparagraph, if a producer of tobacco leaf is also a 
tobacco product manufacturer or controlled by a tobacco product 
manufacturer, the producer shall be subject to this chapter in the 
producer's capacity as a manufacturer. Nothing in this chapter shall be 
construed to grant the Secretary authority to promulgate regulations on 
any matter that involves the production of tobacco leaf or a producer 
thereof, other than activities by a manufacturer affecting production. 
For purposes of the preceding sentence, the term `controlled by' means 
a member of the same controlled group of corporations as that term is 
used in 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. 6. VALIDATION OF FDA RULE.

    Effective one year after the date of the enactment of this Act, 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. 44615-44618) shall take effect under authority of the Federal 
Food, Drug, and Cosmetic Act as amended by this Act. The Secretary 
shall amend the designations of authorities in such regulations 
accordingly.

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:
    ``(i) 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. REPEALS.

    Effective on the date the regulations described in section 566(a) 
of the Federal Food, Drug, and Cosmetic Act take effect--
            (1) the Federal Cigarette Labeling and Advertising Act (15 
        U.S.C. 1331 et seq.), other than sections 6, 8, 10, and 11, is 
        repealed; and
            (2) the Comprehensive Smokeless Tobacco Health Education 
        Act of 1986 (15 U.S.C. 4401 et seq.), other than sections 3(f), 
        5, and 6, is repealed.
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