To express the sense of the Senate concerning legislation requiring reports of serious adverse events related to dietary supplements and over-the-counter drugs.

1. Rewrites the text S.Amdt. 3225 would insert

   Rewrites S.Amdt. 3225In place of the text S.Amdt. 3225 would insert

   In S.Amdt. 3225 as proposed

   SEC. 717. [struck: REPORTING][inserted: SENSE] OF [inserted: THE SENATE CONCERNING ]SERIOUS ADVERSE [struck: HEALTH EXPERIENCES][inserted: EVENT REPORTS].

   Struck: (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.

   ([struck: b][inserted: a]) [struck: Effect of Section][inserted: Definition].--[struck: Notwithstanding ][inserted: In this ]section[struck: ][inserted: , the term "dietary supplement" has the same meaning given the term in section ]201(ff)[struck: (2)] of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)[struck: (2])[struck: ) 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].

   Struck: (c) Definitions.--In this section--

   Struck: (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)).

   Struck: (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--

   Struck: (A) results in--

   Show 11 more struck paragraphsShow less

   Struck: (i) death;

   Struck: (ii) a life-threatening condition;

   Struck: (iii) inpatient hospitalization or prolongation of hospitalization;

   Struck: (iv) a persistent or significant disability or incapacity; or

   Struck: (v) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or

   Struck: (B) requires medical or surgical intervention to prevent 1 of the outcomes described in clauses (i) through (v) in subparagraph (A).

   Struck: (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--

   Struck: (A) speeding metabolism;

   Struck: (B) increasing heart rate;

   Struck: (C) constricting blood vessels; or

   Struck: (D) causing the body to release adrenaline.

   Inserted: (b) Sense of the Senate.--It is the sense of the Senate that--

   Inserted: (1) the Food and Drug Administration should make it a priority to fully and effectively implement the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417, 21 U.S.C. 321 note), including taking appropriate enforcement action against unsafe dietary supplements;

   Inserted: (2) not more than 180 days after the date of enactment of this section, the Department of Health and Human Services should develop a plan for mandatory reporting of serious adverse events occurring as the result of the ingestion of any dietary supplement or over-the-counter drug and provide that plan for review and consideration by Congress; and

   Inserted: (3) adequate resources should be made available for the effective oversight of dietary supplements and for sound scientific research on dietary supplements.

   Original wording

   In lieu of the matter proposed to be inserted, insert the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed