Adverse events

21 U.S.C. § 364a
in effect
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(a) Serious adverse event reporting requirementsThe 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 reportThe 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 informationThe 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 reportsThe 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) ExemptionsThe 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 informationThe 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 section 364e(a) of this title. (e) Maintenance and inspection of adverse event records(1) MaintenanceThe 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 section 364h of this title, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 364h(b) of this title, shall maintain such records for a period of 3 years. (2) 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 personFor 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 ingredientsIf 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 section 552 of title 5, information submitted to the Secretary under this subsection shall be withheld under section 552(b)(3) of title 5. (g) Protected informationA 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) 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. (h) Effect of section(1) In generalNothing 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 informationNotwithstanding 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 reportsNothing 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 constructionThe 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.

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