To require certain dietary supplement manufacturers to report certain serious adverse events.
What it does: Adds SEC. 717. REPORTING OF SERIOUS ADVERSE HEALTH EXPERIENCES on page 147, line 21
Sen. Richard J. Durbin (D-IL)Adds SEC. 717. REPORTING OF SERIOUS ADVERSE HEALTH EXPERIENCES on page 147, line 21
Adds a sectionPrinted pageInserted: SEC. 717. REPORTING OF SERIOUS ADVERSE HEALTH EXPERIENCES.
Inserted: (a) In General.--The Secretary of Defense may not permit a dietary supplement containing a stimulant to be sold on a military installation unless the manufacturer of such dietary supplement submits any report of a serious adverse health experience 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 paragraph (3) of subsection (c), this section does not apply to a dietary supplement containing caffeine that is intended to be consumed in liquid form.
Inserted: (c) Definitions.--In this section--
Inserted: (1) 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) The term "serious adverse health experience" means an adverse event that is 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 condition;
Inserted: (iii) inpatient hospitalization or prolongation of hospitalization;
Inserted: (iv) a persistent or significant disability or incapacity; or
Inserted: (v) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or
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Inserted: (B) requires medical or surgical intervention to prevent 1 of the outcomes described in clauses (i) through (v) in subparagraph (A).
Inserted: (3) 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
On page 147, after line 21, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
On page 147, after line 21, insert the following:
SEC. 717. REPORTING OF SERIOUS ADVERSE HEALTH EXPERIENCES.
(a) In General.--The Secretary of Defense may not permit a dietary supplement containing a stimulant to be sold on a military installation unless the manufacturer of such dietary supplement submits any report of a serious adverse health experience 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 paragraph (3) of subsection (c), this section does not apply to a dietary supplement containing caffeine that is intended to be consumed in liquid form.
(c) Definitions.--In this section--
(1) 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) The term “serious adverse health experience” means an adverse event that is 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 condition;
(iii) inpatient hospitalization or prolongation of hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or
(B) requires medical or surgical intervention to prevent 1 of the outcomes described in clauses (i) through (v) in subparagraph (A).
(3) 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
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Considered by Senate. (consideration: CR S7062, S7077, S7086)
June 21, 2004
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Considered by Senate. (consideration: CR S7062, S7077, S7086)
June 21, 2004
Proposed amendment SA 3225 withdrawn in Senate.
June 21, 2004
Senate amendment proposed (on the floor): Amendment SA 3225 proposed by Senator Durbin.(consideration: CR S7033-7034; text: CR S7033)
June 18, 2004
Amendment SA 3225 proposed by Senator Durbin. (consideration: CR S7033-7034; text: CR S7033) To require certain dietary supplement manufacturers to report certain serious adverse events.
June 18, 2004
Senate amendment submitted
May 20, 2004
Amendments
2 amendmentsOffered to this amendment
Amendments
2 amendmentsOffered to this amendment
No matches
To require certain dietary supplement manufacturers to report certain serious adverse events.
Inserts new text at the in S.Amdt. 3225
Proposed amendment SA 3463 withdrawn in Senate. · Sponsored by Richard J. Durbin · Amends S.Amdt. 3225
To express the sense of the Senate concerning legislation requiring reports of serious adverse events related to dietary supplements and over-the-counter drugs.
Rewrites the text S.Amdt. 3225 would insert
Proposed amendment SA 3462 withdrawn in Senate. · Sponsored by Tom Harkin · Amends S.Amdt. 3225