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21 U.S.C. § 379aa–1 — Serious adverse event reporting for dietary supplements
Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a dietary supplement that is adverse.
(2) **Serious adverse event** — The term “serious adverse event” is an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(3) **Serious adverse event report** — The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
**(b) Reporting requirement**
(1) **In general** — The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to [section 343(e)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/e/1&num=0&edition=prelim)) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the “responsible person”) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
(2) **Retailer** — A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer o
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379aa–1
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Stable record: federal_law:legal_authorities:record_usc_c80682bbf9e9f3aa75dff2fd
Source file: Laws/federal/codes/united-states-code/title-21/section-379aa1-serious-adverse-event-reporting-for-dietary-supplements--f007efdcc6.md
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Passage SHA-256: 92fd1311373cbe0a8014ad6464be3ca07a17b2d28c2907f3bd0475102afc92cc
Source location: Title 21, Chapter 9, § 379aa–1; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Definitions** In this section:
(1) **Adverse event** — The term “adverse event” means any health-related event associated with the use of a dietary supplement that is adverse.
(2) **Serious adverse event** — The term “serious adverse event” is an adverse event that—
(A) results in—
(i) death;
(ii) a life-threatening experience;
(iii) inpatient hospitalization;
(iv) a persistent or significant disability or incapacity; or
(v) a congenital anomaly or birth defect; or
(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
(3) **Serious adverse event report** — The term “serious adverse event report” means a report that is required to be submitted to the Secretary under subsection (b).
**(b) Reporting requirement**
(1) **In general** — The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to [section 343(e)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/e/1&num=0&edition=prelim)) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the “responsible person”) shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
(2) **Retailer** — A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in [section 343(y) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/y&num=0&edition=prelim).
**(c) Submission of reports**
(1) **Timing of reports** — The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in [section 343(y) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/y&num=0&edition=prelim).
(2) **New medical information** — The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.
(3) **Consolidation of reports** — The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.
(4) **Exemption** — The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.
**(d) Contents of reports** Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.
**(e) Maintenance and inspection of records**
(1) **Maintenance** — The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.
(2) **Records 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) Protected information** A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report 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.
**(g) Rule of construction** The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.
**(h) Preemption**
(1) **In general** — No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.
(2) **Effect of section**
(A) *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.
(B) *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—
(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or
(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.
(C) *Use of safety 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 subsection (g) or [section 379v of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379v&num=0&edition=prelim).
**(i) Authorization of appropriations** There are authorized to be appropriated to carry out this section such sums as may be necessary.
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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
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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
A food shall be deemed to be misbranded—
**(a) False or misleading label** If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to which [section 350 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350&num=0&edition=prelim) applies, its advertising is false or misleading in a material respect or its labeling is in violation of [section 350(b)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350/b/2&num=0&edition=prelim).
**(b) Offer for sale under another name** If it is offered for sale under the name of another food.
**(c) Imitation of another food** If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated.
**(d) Misleading container** If its container is so made, formed, or filled as to be misleading.
**(e) Package form** If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, except that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
**(f) Prominence of information on label** If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and unde
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 343
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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.