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Title 21, Food and DrugsRelease 119-110

§379aa–1 Serious Adverse Event Reporting for Dietary Supplements

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VII — GENERAL AUTHORITY › Part H — Serious Adverse Event Reports › § 379aa–1

Last updated Sep 22, 2026|Official source

Summary

Manufacturers, packers, or distributors whose name is on a dietary supplement label must send the federal government any report they get about a serious health problem tied to that supplement and include a copy of the product label. An "adverse event" is any health problem linked to a supplement. A "serious adverse event" is one that causes death, is life‑threatening, leads to inpatient hospitalization, causes lasting disability, results in a birth defect, or needs medical or surgical action to prevent those outcomes. A "serious adverse event report" is the required report the company must send. The responsible company must file the report using the MedWatch form within 15 business days after getting the report through the required contact. If the company gets new medical information about that event within 1 year, it must send that new information within 15 business days. The government will combine duplicate reports. The company must keep related records for 6 years and let authorized HHS inspectors review them. Reports are treated as safety records and are protected so personal information is redacted before public release. Sending a report is not an admission that the product caused the problem. States may not have different mandatory reporting systems, although the federal agency may share reports with state officials under agreements. Funds are authorized as needed to run the program.

Full Legal Text

Title 21, §379aa–1

Food and Drugs, Source: USLM XML via OLRC

(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
The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
(b)Reporting requirement
(1)In general
The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 343(e)(1) of this title) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the “responsible person”) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
(2)Retailer
A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in section 343(y) of this title.
(c)Submission of reports
(1)Timing of reports
The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 343(y) of this title.
(2)New medical information
The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
(3)Consolidation of reports
The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
(4)Exemption
The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.
(d)Contents of reports
Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.
(e)Maintenance and inspection of records
(1)Maintenance
The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.
(2)Records inspection
(A)In general
The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.
(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
The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.
(h)Preemption
(1)In general
No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.
(2)Effect of section
(A)In general
Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.
(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
Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or section 379v of this title.
(i)Authorization of appropriations
There are authorized to be appropriated to carry out this section such sums as may be necessary.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as an

Effective Date

of 2006 Amendment note under section 343 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 379aa–1

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110