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21 U.S.C. § 379v — Safety report disclaimers
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
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Stable record: federal_law:legal_authorities:record_usc_e6b3159d3e5ce870acec8a5b
Source file: Laws/federal/codes/united-states-code/title-21/section-379v-safety-report-disclaimers--95695fb81f.md
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Passage SHA-256: b02315e2ba378c9c98e566e8d1952cc497b83de7e4b4b56d782b7328fb8f1c96
Source location: Title 21, Chapter 9, § 379v; chapter-009-federal-food-drug-and-cosmetic-act.md
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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.
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Federal law — U.S. Code and appendices · legal_authorities
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Responsible party** — The term “responsible party”, with respect to an article of food, means a person that submits the registration under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim) for a food facility that is required to register under [section 350d(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d/a&num=0&edition=prelim), at which such article of food is manufactured, processed, packed, or held.
(2) **Reportable food** — The term “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.
**(b) Establishment**
(1) **In general** — Not later than 1 year after September 27, 2007, the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from—
(A) Federal, State, and local public health officials; or
(B) responsible parties.
(2) **Review by Secretary** — The Secretary shall promptly review and assess the information submitted under paragraph (1) for the purposes of identifying reportable food, submitting entries to the Reportable Food Registry, acting under subsection (c), and exercising other existing food safety authorities under this chapter to protect the public health.
**(c) Issuance of an alert by the Secretary**
(1) **In general** — The Secretary shall issue, or cause to be issued, an a
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350f
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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
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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 nonprescription drug that is adverse, including—
(A) an event occurring from an overdose of the drug, whether accidental or intentional;
(B) an event occurring from abuse of the drug;
(C) an event occurring from withdrawal from the drug; and
(D) any failure of expected pharmacological action of the drug.
(2) **Nonprescription drug** — The term “nonprescription drug” means a drug that is—
(A) not subject to [section 353(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b&num=0&edition=prelim); and
(B) not subject to approval in an application submitted under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim).
(3) **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).
(4) **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 whose name (pursuant to [section 352(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section352/b/1&num=0&edition=preli
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379aa
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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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Federal law — U.S. Code and appendices · legal_authorities
Page 628
TITLE 21—FOOD AND DRUGS
§ 379s
§ 379s. Preemption for labeling or packaging of
cosmetics
(a) In general
Except as provided in subsection (b), (d), or (e),
no State or political subdivision of a State may
establish or continue in effect any requirement
for labeling or packaging of a cosmetic that is
different from or in addition to, or that is other-
wise not identical with, a requirement specifi-
cally applicable to a particular cosmetic or class
of cosmetics under this chapter, the Poison Pre-
vention Packaging Act of 1970 (15 U.S.C. 1471 et
seq.), or the Fair Packaging and Labeling Act
(15 U.S.C. 1451 et seq.).
(b) Exemption
Upon application of a State or political sub-
division thereof, the Secretary may by regula-
tion, after notice and opportunity for written
and oral presentation of views, exempt from sub-
section (a), under such conditions as may be pre-
scribed in such regulation, a State or political
subdivision requirement for labeling or pack-
aging that—
(1) protects an important public interest
that would otherwise be unprotected;
(2) would not cause a cosmetic to be in viola-
tion of any applicable requirement or prohibi-
tion under Federal law; and
(3) would not unduly burden interstate com-
merce.
(c) Scope
For purposes of subsection (a), a reference to
a State requirement that relates to the pack-
aging or labeling of a cosmetic means any spe-
cific requirement relating to the same aspect of
such cosmetic as a requirement specifically ap-
plicable to that particular cosmetic or class of
cosmetics under this chapter for packaging or
labeling, including any State requirement relat-
ing to public information or any other form of
public communication.
(d) No effect on product liability law
Nothing in this section shall be
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 379v
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.