21 U.S. Code § 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) 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), 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) Clarification.—

For the purposes of subparagraph (B)(viii), the terms “packaging” and “repackaging” do not include filling a product container with a cosmetic product.

(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) 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 obtained 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, including the amendments made by this subtitle, shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.”