21 U.S.C. § 364a — Adverse events

(a) Serious adverse event reporting requirements: The responsible person must send the Secretary any report they receive of a serious adverse event linked to using, in the United States, a cosmetic product they manufactured, packed, or distributed. (b) Submission of reports: (1) A serious adverse event report must go to the Secretary along with a copy of the product's retail label, no later than 15 business days after the responsible person receives the report. (2) If the responsible person later gets new, material medical information about that same event, within one year of the first report, they must send it to the Secretary within 15 business days of getting it. (3) The Secretary must build a system letting responsible persons submit one combined report instead of duplicates, when reports repeat or add new medical information about the same event. (c) Exemptions: The Secretary can create, by regulation, an exemption from any requirement in this section, if the Secretary finds the exemption would not significantly hurt public health. (d) Contact information: The responsible person must receive adverse event reports through the domestic address, phone number, or electronic contact listed on the product's label under section 364e(a). (e) Maintenance and inspection of adverse event records: (1) The responsible person must keep records of every adverse event report they receive for 6 years. Small businesses, as defined in section 364h, that do not manufacture or process the higher-risk cosmetics listed in section 364h(b), only need to keep these records for 3 years. (2)(A) The responsible person must let an authorized inspector see these records during an inspection under section 374. (B) An "authorized person" is a Department of Health and Human Services officer or employee who has proper credentials, as the Secretary decides, and whom the Secretary has specifically assigned to access these records. (f) Fragrance and flavor ingredients: If the Secretary reasonably believes an ingredient in a fragrance or flavor caused or contributed to a reportable serious adverse event, the Secretary can request, in writing, a list of the ingredients or ingredient categories in that fragrance or flavor from the responsible person. The responsible person must submit that list within 30 days. If someone requests this information under the Freedom of Information Act, section 552 of title 5, it must be withheld under section 552(b)(3) of title 5. (g) Protected information: A serious adverse event report, including new medical information, or any adverse event report or new information voluntarily submitted, counts as: (1) a "safety report" under section 379v, which may come with a statement, that becomes part of any publicly released report, denying that the report admits the product caused the event; and (2) a protected record under the Privacy Act, section 552a of title 5, and a medical file protected from disclosure under the Freedom of Information Act, section 552 of title 5, meaning it cannot be publicly released unless all personally identifiable information is blacked out. (h) Effect of section: (1) This section does not limit the Secretary's power to share adverse event reports and information with state, territory, or local health, food, or drug officials under a formal agreement. (2) But personally identifiable information the Secretary shares that way cannot be made public under any state disclosure law, and cannot otherwise be shared further without written consent from both the Secretary and the person who originally submitted it. (3) A state or locality cannot use a safety report it gets from the Secretary in a way that conflicts with this section. (4) Submitting a report as this section requires is not an admission that the cosmetic product caused or contributed to the adverse event.