21 U.S.C. § 364a | Adverse events

(a)

Serious adverse event reporting requirements

The responsible person shall submit to the Secretary any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person.

(b)

Submission of reports

(1)

Serious adverse event report

The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person.

(2)

New medical information

The responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.

(3)

Consolidation of reports

The Secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event.

(c)

Exemptions

The Secretary may establish by regulation an exemption to any of the requirements of this section if the Secretary determines that such exemption would have no significant adverse effect on public health.

(d)

Contact information

section 364e(a) of this titleThe responsible person shall receive reports of adverse events through the domestic address, domestic telephone number, or electronic contact information included on the label in accordance with .

(e)

Maintenance and inspection of adverse event records

(1)

Maintenance

section 364h of this title section 364h(b) of this titleThe responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of , who does not engage in the manufacturing or processing of the cosmetic products described in sub, shall maintain such records for a period of 3 years.

(2)

Inspection

(A)

In general

section 374 of this title 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 .

(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)

Fragrance and flavor ingredients

section 552 of title 5 section 552(b)(3) of title 5If the Secretary 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 required to be reported under this section, the Secretary may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product, from the responsible person. The responsible person shall ensure that the requested information is submitted to the Secretary within 30 days of such request. In response to a request under , information submitted to the Secretary under this subsection shall be withheld under .

(g)

Protected information

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

(1)

section 379v of this title a safety report under 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)

section 552a of title 5 a record about an individual under (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.

(h)

Effect of section

(1)

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.

(2)

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—

(A)

be made publicly available pursuant to any State 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 and the person submitting such information to the Secretary.

(3)

Use of 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 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 involved caused or contributed to the relevant adverse event.

June 25, 1938, ch. 675, § 605 Pub. L. 117–328, div. FF, title III, § 3502Dec. 29, 2022136 Stat. 5848(, as added , , .)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

section 3502 of Pub. L. 117–328 section 331(j) of this title section 1905 of title 18 section 552(b)(4) of title 5 section 3503(c)(2) of Pub. L. 117–328 section 364 of this titleNothing in , which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under or or that is subject to withholding under , see , set out as a note under .