S.Amdt. 1276

SA 1276. Mr. ENZI submitted an amendment intended to be proposed to
amendment SA 1247 proposed by Mr. Dodd to the bill H.R. 1256, to
protect the public health by providing the Food and Drug Administration
with certain authority to regulate tobacco products, to amend title 5,
United States Code, to make certain modifications in the Thrift Saving
Plan, the Civil Service Retirement System, and the Federal Employees'
Retirement System, and for other purposes; which was ordered to lie on
the table; as follows:

In section 908 of the Federal Food Drug, and Cosmetic Act
(as added by section 101), add at the end the following:
``(d) Imminent Hazards.--
``(1) In general.--If the Secretary finds that the
marketing, distribution, or advertising of a tobacco product
poses an imminent hazard to the public health, the Secretary
may--
``(A) provide for the recall of the product under
subsection (c);
``(B) suspend to approval of a label statement for the
product under section 903(b);
``(C) suspend the approval of the application of the
product under section 910; or
``(D) take any other action with respect to the product
under this title to protect the public health.
``(2) Notice.--The Secretary shall provide the manufacturer
or distributor of a tobacco product (as the case may be)
prompt notice of any action taken under paragraph (1) with
respect to such product, and afford the manufacturer or
distributor the opportunity for an expedited hearing under
this subsection.
``(3) Standard for determination.--
``(A) In general.--For purposes of this subsection, the
marketing, distribution, or advertising or a tobacco product
poses an imminent hazard to the public health if the
Secretary determines that the evidence is sufficient to
demonstrate that the product (or practice involved) creates a
public health situation--
``(i) that should be corrected immediately to prevent
injury; and
``(ii) that should not be permitted to continue while a
hearing or other formal proceeding is being held.
``(B) Time of declaration.--An imminent hazard may be
declared under this subsection at any point in the chain of
events that may ultimately result in harm to the public
health. The occurrence of the final anticipated injury is not
essential to establish that an imminent hazard of such
occurrence exists.
``(C) Considerations.--In exercising the judgment of the
Secretary on whether an imminent hazard exists for purposes
of this subsection, the Secretary shall consider the number
of injuries anticipated and the nature, severity, and
duration of the anticipated injury.''.
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