21 U.S. Code § 379aa-1. Serious adverse event reporting for dietary supplements

(a) DefinitionsIn this section:

(1) Adverse event

The term “adverse event” means any health-related event associated with the use of a dietary supplement that is adverse.

(2) Serious adverse eventThe term “serious adverse event” is an adverse event that—

(A) results in—

(i)

death;

(ii)

a life-threatening experience;

(iii)

inpatient 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, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(3) Serious adverse event report

The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).

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