21 U.S.C. § 364 — Definitions

(1) Adverse event: An "adverse event" means any health-related event tied to using a cosmetic product, if that event is adverse. (2) Cosmetic product: A "cosmetic product" means a preparation of cosmetic ingredients that has a specific, set recipe, both what is in it and how much, made for use as a finished product. (3) Facility: (A) In general, a "facility" includes any place, including a place run by an importer, that manufactures or processes cosmetic products sold in the United States. (B) But "facility" does not include: (i) beauty shops and salons, unless they manufacture or process cosmetics on-site; (ii) cosmetic retailers, including individual sales representatives, direct sellers, retail distribution centers, and pharmacies, unless they manufacture or process cosmetics that are not sold directly to customers there; (iii) hospitals, doctors' offices, and health clinics; (iv) public health agencies and nonprofits that give cosmetics directly to consumers; (v) businesses like hotels and airlines that give out free cosmetics as part of another service; (vi) trade shows and similar places giving out free cosmetic samples; (vii) places that make cosmetics solely for research, evaluation, or production testing, not for retail sale; and (viii) places that only label, relabel, package, repackage, hold, or distribute cosmetics. (C) For that last exception, "packaging" and "repackaging" do not include simply filling a product container with a cosmetic. (4) Responsible person: The "responsible person" is the manufacturer, packer, or distributor whose name appears on the cosmetic's label, as required by section 364e(a) of this title or section 1453(a) of title 15. (5) Serious adverse event: An adverse event is "serious" if it either (A) results in death, a life-threatening experience, hospitalization as an inpatient, a lasting or major disability, a birth defect, an infection, or significant disfigurement, such as serious ongoing rashes, second- or third-degree burns, major hair loss, or a lasting change in appearance, beyond what is intended under normal, expected use, or (B) requires medical or surgical treatment, based on reasonable medical judgment, to prevent one of those outcomes from happening.