---
kind: "section"
citation: "21 U.S.C. § 364a"
title: "21"
title_heading: "Food and Drugs"
number: "364a"
heading: "Adverse events"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/364a"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VI — Cosmetics"
---

# §364a. Adverse events

- (a) **Serious adverse event reporting requirements—** The [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) any report received of a [serious adverse event](/usc/21/364.md?p=5) associated with the use, in the United States, of a [cosmetic product](/usc/21/364.md?p=2) manufactured, packed, or distributed by such [person](/usc/21/321.md?p=e).
- (b) **Submission of reports—**
  - (1) **Serious adverse event report—** The [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) a [serious adverse event](/usc/21/364.md?p=5) report accompanied by a copy of the [label](/usc/21/321.md?p=k) on or within the retail [packaging](/usc/21/364.md?p=3-C) of such [cosmetic product](/usc/21/364.md?p=2) no later than 15 business days after the report is received by the [responsible person](/usc/21/364.md?p=4).
  - (2) **New medical information—** The [responsible person](/usc/21/364.md?p=4) shall submit to the [Secretary](/usc/21/321.md?p=d) any new and material medical information, related to a [serious adverse event](/usc/21/364.md?p=5) report submitted to the [Secretary](/usc/21/321.md?p=d) in accordance with [paragraph (1)](#b-1), that is received by the [responsible person](/usc/21/364.md?p=4) within 1 year of the initial report to the [Secretary](/usc/21/321.md?p=d), no later than 15 business days after such information is received by such [responsible person](/usc/21/364.md?p=4).
  - (3) **Consolidation of reports—** The [Secretary](/usc/21/321.md?p=d) shall develop systems to enable [responsible persons](/usc/21/364.md?p=4) to submit a single report that includes duplicate reports of, or new medical information related to, a [serious adverse event](/usc/21/364.md?p=5).
- (c) **Exemptions—** The [Secretary](/usc/21/321.md?p=d) may establish by regulation an exemption to any of the requirements of this section if the [Secretary](/usc/21/321.md?p=d) determines that such exemption would have no significant adverse effect on public health.
- (d) **Contact information—** The [responsible person](/usc/21/364.md?p=4) shall receive reports of [adverse events](/usc/21/364.md?p=1) through the domestic address, domestic telephone number, or electronic contact information included on the [label](/usc/21/321.md?p=k) in accordance with [section 364e(a) of this title](/usc/21/364e.md?p=a).
- (e) **Maintenance and inspection of adverse event records—**
  - (1) **Maintenance—** The [responsible person](/usc/21/364.md?p=4) shall maintain records related to each report of an [adverse event](/usc/21/364.md?p=1) associated with the use, in the United States, of a [cosmetic product](/usc/21/364.md?p=2) manufactured or distributed by such [person](/usc/21/321.md?p=e) received by such [person](/usc/21/321.md?p=e), for a period of 6 years, except that a [responsible person](/usc/21/364.md?p=4) that is considered a small business for the purposes of [section 364h of this title](/usc/21/364h.md), who does not engage in the manufacturing or processing of the [cosmetic products](/usc/21/364.md?p=2) described in sub[section 364h(b) of this title](/usc/21/364h.md?p=b), shall maintain such records for a period of 3 years.
  - (2) **Inspection—**
    - (A) **In general—** The [responsible person](/usc/21/364.md?p=4) shall permit an [authorized](/usc/21/360eee.md?p=2) [person](/usc/21/321.md?p=e) to have access to records required to be maintained under this section during an inspection pursuant to [section 374 of this title](/usc/21/374.md).
    - (B) **Authorized person—** For purposes of this paragraph, the term “[authorized](/usc/21/360eee.md?p=2) [person](/usc/21/321.md?p=e)” means an officer or employee of the [Department](/usc/21/321.md?p=c) of Health and Human Services who has—
      - (i) appropriate credentials, as determined by the [Secretary](/usc/21/321.md?p=d); and
      - (ii) been duly designated by the [Secretary](/usc/21/321.md?p=d) to have access to the records required under this section.
- (f) **Fragrance and flavor ingredients—** If the [Secretary](/usc/21/321.md?p=d) has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a [serious adverse event](/usc/21/364.md?p=5) required to be reported under this section, the [Secretary](/usc/21/321.md?p=d) may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the [cosmetic product](/usc/21/364.md?p=2), from the [responsible person](/usc/21/364.md?p=4). The [responsible person](/usc/21/364.md?p=4) shall ensure that the requested information is submitted to the [Secretary](/usc/21/321.md?p=d) within 30 days of such request. In response to a request under [section 552 of title 5](/usc/5/552.md), information submitted to the [Secretary](/usc/21/321.md?p=d) under this subsection shall be withheld under [section 552(b)(3) of title 5](/usc/5/552.md?p=b-3).
- (g) **Protected information—** A [serious adverse event](/usc/21/364.md?p=5) report submitted to the [Secretary](/usc/21/321.md?p=d) under this section, including any new medical information submitted under [subsection (b)(2)](#b-2), or an [adverse event](/usc/21/364.md?p=1) report, or any new information, voluntarily submitted to the [Secretary](/usc/21/321.md?p=d) shall be considered to be—
  - (1) a safety report under [section 379v of this title](/usc/21/379v.md) 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](/usc/21/360eee.md?p=13) involved caused or contributed to the [adverse event](/usc/21/364.md?p=1); and
  - (2) a record about an individual under [section 552a of title 5](/usc/5/552a.md) (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](/usc/5/552.md) of such [title 5](/usc/5.md) (commonly referred to as the “Freedom of Information Act”), and shall not be publicly disclosed unless all personally identifiable information is redacted.
- (h) **Effect of section—**
  - (1) **In general—** Nothing in this section shall affect the authority of the [Secretary](/usc/21/321.md?p=d) to provide [adverse event](/usc/21/364.md?p=1) reports and information to any health, [food](/usc/21/321.md?p=f), or [drug](/usc/21/321.md?p=g-1) officer or employee of any [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), under a memorandum of understanding between the [Secretary](/usc/21/321.md?p=d) and such [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision.
  - (2) **Personally identifiable information—** Notwithstanding any other provision of law, personally-identifiable information in [adverse event](/usc/21/364.md?p=1) reports provided by the [Secretary](/usc/21/321.md?p=d) to any health, [food](/usc/21/321.md?p=f), or [drug](/usc/21/321.md?p=g-1) officer or employee of any [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), shall not—
    - (A) be made publicly available pursuant to any [State](/usc/21/321.md?p=a-1) or other law requiring disclosure of information or records; or
    - (B) otherwise be disclosed or distributed to any party without the written consent of the [Secretary](/usc/21/321.md?p=d) and the [person](/usc/21/321.md?p=e) submitting such information to the [Secretary](/usc/21/321.md?p=d).
  - (3) **Use of reports—** Nothing in this section shall permit a [State](/usc/21/321.md?p=a-1), [territory](/usc/21/321.md?p=a-2), or political subdivision of a [State](/usc/21/321.md?p=a-1) or [territory](/usc/21/321.md?p=a-2), to use any safety report received from the [Secretary](/usc/21/321.md?p=d) in a manner inconsistent with this section.
  - (4) **Rule of construction—** The submission of any report in compliance with this section shall not be construed as an admission that the [cosmetic product](/usc/21/364.md?p=2) involved caused or contributed to the relevant [adverse event](/usc/21/364.md?p=1).

## Source credit

(June 25, 1938, ch. 675, § 605, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5848.)

## Notes

### Statutory Notes and Related Subsidiaries

### Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.