To require certain dietary supplement manufacturers to report certain serious adverse events.
What it does: Adds SEC. 330. REPORTING OF SERIOUS ADVERSE HEALTH EVENTS at the end of subtitle C of title III
Sen. Richard J. Durbin (D-IL)What it changes
1 change to S. 1042 · shown in the bill's text
Adds SEC. 330. REPORTING OF SERIOUS ADVERSE HEALTH EVENTS at the end of subtitle C of title III
Adds a sectionIn S. 1042 · Placed on Calendar Senate
(d) Ethanol Fuel Defined.--In this section, the term "ethanol fuel" means fuel that is 85 percent ethyl alcohol.
Inserted: SEC. 330. REPORTING OF SERIOUS ADVERSE HEALTH EVENTS.
Inserted: (a) In General.--The Secretary of Defense may not permit a dietary supplement containing a stimulant to be sold on a military installation or in a commissary store, exchange store, or other store under chapter 147 of title 10, United States Code, unless the manufacturer of such dietary supplement submits any report of a serious adverse health event associated with such dietary supplement to the Secretary of Health and Human Services, who shall make such reports available to the Surgeon Generals of the Armed Forces.
Inserted: (b) Effect of Section.--Notwithstanding section 201(ff)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(2)) and subsection (c)(3) of this section, this section shall not apply to a dietary supplement that is intended to be consumed in liquid form if the only stimulant contained in such supplement is caffeine.
Inserted: (c) Definitions.--In this section:
Inserted: (1) Dietary supplement.--The term "dietary supplement" has the same meaning given the term in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
Inserted: (2) Serious adverse health event.--The term "serious adverse health event" means an adverse event that may reasonably be suspected to be associated with the use of a dietary supplement in a human, without regard to whether the event is known to be causally related to the dietary supplement, that--
Inserted: (A) results in--
Inserted: (i) death;
Inserted: (ii) a life-threatening experience;
Inserted: (iii) inpatient hospitalization or prolongation of an existing hospitalization;
Inserted: (iv) a persistent or significant disability or incapacity; or
Inserted: (v) a congenital anomaly or birth defect; or
Show 6 more inserted paragraphsShow less
Inserted: (B) requires, based on reasonable medical judgment, medical or surgical intervention to prevent an outcome described in subparagraph (A).
Inserted: (3) Stimulant.--The term "stimulant" means a dietary ingredient that has a stimulant effect on the cardiovascular system or the central nervous system of a human by any means, including--
Inserted: (A) speeding metabolism;
Inserted: (B) increasing heart rate;
Inserted: (C) constricting blood vessels; or
Inserted: (D) causing the body to release adrenaline.
Original wording
At the end of subtitle C of title III, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 1379. Mr. DURBIN (for himself and Mrs. Feinstein) proposed an amendment to the bill S. 1042, to authorize appropriations for fiscal year 2006 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe personnel strengths for such fiscal year for the Armed Forces, and for other purposes; as follows:
At the end of subtitle C of title III, add the following:
SEC. 330. REPORTING OF SERIOUS ADVERSE HEALTH EVENTS.
(a) In General.--The Secretary of Defense may not permit a dietary supplement containing a stimulant to be sold on a military installation or in a commissary store, exchange store, or other store under chapter 147 of title 10, United States Code, unless the manufacturer of such dietary supplement submits any report of a serious adverse health event associated with such dietary supplement to the Secretary of Health and Human Services, who shall make such reports available to the Surgeon Generals of the Armed Forces.
(b) Effect of Section.--Notwithstanding section 201(ff)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(2)) and subsection (c)(3) of this section, this section shall not apply to a dietary supplement that is intended to be consumed in liquid form if the only stimulant contained in such supplement is caffeine.
(c) Definitions.--In this section:
(1) Dietary supplement.--The term “dietary supplement” has the same meaning given the term in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)).
(2) Serious adverse health event.--The term “serious adverse health event” means an adverse event that may reasonably be suspected to be associated with the use of a dietary supplement in a human, without regard to whether the event is known to be causally related to the dietary supplement, that--
(A) results in--
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization or prolongation of an existing hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, medical or surgical intervention to prevent an outcome described in subparagraph (A).
(3) Stimulant.--The term “stimulant” means a dietary ingredient that has a stimulant effect on the cardiovascular system or the central nervous system of a human by any means, including--
(A) speeding metabolism;
(B) increasing heart rate;
(C) constricting blood vessels; or
(D) causing the body to release adrenaline.
Legislative Activity
Stay on top of the latest movement without scrolling through every action
Measure laid before Senate by unanimous consent. (consideration: CR S12377)
November 4, 2005
View full timeline
Measure laid before Senate by unanimous consent. (consideration: CR S12377)
November 4, 2005
Proposed amendment SA 1379 withdrawn in Senate.
November 4, 2005
Considered by Senate. (consideration: CR S8897)
July 26, 2005
Considered by Senate. (consideration: CR S8772)
July 25, 2005
Considered by Senate. (consideration: CR S8717)
July 22, 2005
Senate amendment submitted
July 21, 2005
Senate amendment proposed (on the floor): Amendment SA 1379 proposed by Senator Durbin.
July 21, 2005
Amendment SA 1379 proposed by Senator Durbin. (consideration: CR S8635-8638; text: CR S8635) To require certain dietary supplement manufacturers to report certain serious adverse events.
July 21, 2005