Us Code § 364 - Definitions
Full text of Us Code United States Code § 364 — Definitions, with citation guidance and answers to common questions.
§ 364. Definitions
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)
(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), 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.
(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:
(I) Labeling.
(II) Relabeling.
(III) Packaging.
(IV) Repackaging.
(V) Holding.
(VI) Distributing.
(C)
(4) Responsible person
The term "responsible person" means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 364e(a) of this title or section 1453(a) of title 15.
(5) Serious adverse event
The term "serious adverse event" means 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;
(v) a congenital anomaly or birth defect;
(vi) an infection; or
(vii) significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), 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 subparagraph (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 regulations 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)
"(2)
About This Section
21 U.S.C. § 364 is part of Title 21 of the United States Code. The United States Code is the official codification of federal statutes maintained by the Office of the Law Revision Counsel of the U.S. House of Representatives. Congress amends the Code through new public laws, which are eventually incorporated into the relevant title.
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