Browse Arkansas Code titles and sections
21 U.S.C. § 364a — Adverse events
Federal law — U.S. Code and appendices · legal_authorities
**(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** The 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-pr
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364a
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: 4f2844ed00a9c14c177eafeea7235fed80cd266d1600fead5009e18d460b7aa5. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Open the recorded source website ↗
Record provenance
Stable record: federal_law:legal_authorities:record_usc_9ec96fba26c8950dfc7f2d97
Source file: Laws/federal/codes/united-states-code/title-21/section-364a-adverse-events--926ae53320.md
Pages: Not recorded – Not recorded
Passage SHA-256: f33102e3422496898c178df1eee381d20e70d5f4ae1484633339052dff68d49b
Source location: Title 21, Chapter 9, § 364a; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(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** The 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364e/a&num=0&edition=prelim).
**(e) Maintenance and inspection of adverse event records**
(1) **Maintenance** — The 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364h&num=0&edition=prelim), who does not engage in the manufacturing or processing of the cosmetic products described in sub[section 364h(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section364h/b&num=0&edition=prelim), 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim).
(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** If 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim), information submitted to the Secretary under this subsection shall be withheld under [section 552(b)(3) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/3&num=0&edition=prelim).
**(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) a safety report under [section 379v of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379v&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552a&num=0&edition=prelim) (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.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
In this subchapter:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a cosmetic product that is adverse.
(2) **Cosmetic product** — The term “cosmetic product” means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.
(3) **Facility**
(A) *In general.—* — The term “facility” includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(B) Such term does not include any of the following:
(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in [section 3508(b)(2) of title 26](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section3508/b/2&num=0&edition=prelim)), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location.
(iii) Hospitals, physicians’ offices, and health care clinics.
(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.
(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.
(vii) An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
(vii
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions.—** For purposes of this section—
(1) the term “agency” means agency as defined in section 552(e) 11 See References in Text note below. of this title;
(2) the term “individual” means a citizen of the United States or an alien lawfully admitted for permanent residence;
(3) the term “maintain” includes maintain, collect, use, or disseminate;
(4) the term “record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his education, financial transactions, medical history, and criminal or employment history and that contains his name, or the identifying number, symbol, or other identifying particular assigned to the individual, such as a finger or voice print or a photograph;
(5) the term “system of records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual;
(6) the term “statistical record” means a record in a system of records maintained for statistical research or reporting purposes only and not used in whole or in part in making any determination about an identifiable individual, except as provided by [section 8 of title 13](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title13-section8&num=0&edition=prelim);
(7) the term “routine use” means, with respect to the disclosure of a record, the use of such record for a purpose which is compatible with the purpose for which it was collected;
(8) the term “matching program”—
(A) means any computerized comparison of—
(i) two or more automated systems of records or a system of records with non-Federal records for the purpose
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552a
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 374
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379v
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
**(b) Requirements applicable to all manufacturers and processors of cosmetics** The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:
(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
(2) Cosmetic products that are injected.
(3) Cosmetic products that are intended for internal use.
(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 364h
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 483
TITLE 21—FOOD AND DRUGS
§ 364a
(vii) significant disfigurement (including
serious and persistent rashes, second- or
third-degree burns, significant hair loss, or
persistent or significant alteration of ap-
pearance), other than as intended, under
conditions of use that are customary or
usual; or
(B) requires, based on reasonable medical
judgment, a medical or surgical intervention
to prevent an outcome described in subpara-
graph (A).
(June 25, 1938, ch. 675, § 604, as added Pub. L.
117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136
Stat. 5847.)
Editorial Notes
PRIOR PROVISIONS
A prior section 364, act June 25, 1938, ch. 675, § 604, 52
Stat. 1055, directed Secretary to promulgate regula-
tions for listing of coal-tar colors for cosmetics, prior
to repeal by Pub. L. 86–618, title I, § 103(a)(3), July 12,
1960, 74 Stat. 398, effective July 12, 1960. See section 379e
of this title.
Statutory Notes and Related Subsidiaries
CONSTRUCTION; CONFIDENTIALITY
Pub. L. 117–328, div. FF, title III, § 3503(c), Dec. 29,
2022, 136 Stat. 5859, provided that:
‘‘(1) IN
GENERAL.—The Secretary [of Health and
Human Services] shall take appropriate measures to
ensure that there are in effect effective procedures to
prevent the unauthorized disclosure of any trade secret
or confidential commercial information that is ob-
tained by the Secretary of Health and Human Services
pursuant to this subtitle [subtitle E (§§ 3501–3508) of
title III of div. FF of Pub. L. 117–328, see Short Title of
2022 Amendment set out under section 301 of this title],
including the amendments made by this subtitle.
‘‘(2) CLARIFICATION.—Nothing in this subtitle, includ-
ing the amendments made by this subtitle, shall be
construed to authorize the disclosure of information
tha
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 364a
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.