21 USC 379aa-1 - Serious adverse event reporting for dietary supplements

U.S Code last checked for updates: Apr 29, 2024

§ 379aa–1.

Serious adverse event reporting for dietary supplements

(a)

Definitions

In this section:

(1)

Adverse event

(2)

Serious adverse event

The 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

(b)

Reporting requirement

(1)

In general

(2)

Retailer

(c)

Submission of reports

(1)

Timing of reports

(2)

New medical information

(3)

Consolidation of reports

(4)

Exemption

(d)

Contents of reports

(e)

Maintenance and inspection of records

(1)

Maintenance

(2)

Records inspection

(A)

In general

(B)

Authorized person

For purposes of this paragraph, the term “authorized person” means an officer or employee of the Department of Health and Human Services, who has—

(i)

appropriate credentials, as determined by the Secretary; and

(ii)

been duly designated by the Secretary to have access to the records required under this section.

(f)

Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—

(1)

a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2)

a record about an individual under section 552a of title 5 (commonly referred to as the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the “Freedom of Information Act”), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(g)

Rule of construction

(h)

Preemption

(1)

In general

(2)

Effect of section

(A)

In general

(B)

Personally-identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(i)

be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(ii)

otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(C)

Use of safety reports

(i)

Authorization of appropriations

(June 25, 1938, ch. 675, § 761, as added Pub. L. 109–462, § 3(a), Dec. 22, 2006, 120 Stat. 3472.)

cite as: 21 USC 379aa-1