{"identifier":"/us/usc/t21/s364","title":21,"num":"\u00a7\u202f364.","heading":"Definitions","text":"\u00a7\u202f364.\nDefinitions\nIn this subchapter:\n(1)\nAdverse event\nThe term \u201cadverse event\u201d means any health-related event associated with the use of a cosmetic product that is adverse.\n(2)\nCosmetic product\nThe term \u201ccosmetic product\u201d means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.\n(3)\nFacility\n(A)\nIn general.\u2014\nThe term \u201cfacility\u201d includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.\n(B) Such term does not include any of the following:\n(i) Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.\n(ii) Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in\nsection 3508(b)(2) of title 26\n(iii) Hospitals, physicians\u2019 offices, and health care clinics.\n(iv) Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.\n(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.\n(vi) Trade shows and other venues where cosmetic product samples are provided free of charge.\n(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.\n(viii) An establishment that solely performs one or more of the following with respect to cosmetic products:\n(I) Labeling.\n(II) Relabeling.\n(III) Packaging.\n(IV) Repackaging.\n(V) Holding.\n(VI) Distributing.\n(C)\nClarification.\u2014\nFor the purposes of subparagraph (B)(viii), the terms \u201cpackaging\u201d and \u201crepackaging\u201d do not include filling a product container with a cosmetic product.\n(4)\nResponsible person\nThe term \u201cresponsible person\u201d means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with\nsection 364e(a) of this title\nsection 1453(a) of title 15\n(5)\nSerious adverse event\nThe term \u201cserious adverse event\u201d means an adverse event that\u2014\n(A) results in\u2014\n(i) death;\n(ii) a life-threatening experience;\n(iii) inpatient hospitalization;\n(iv) a persistent or significant disability or incapacity;\n(v) a congenital anomaly or birth defect;\n(vi) an infection; or\n(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\n(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).","url":"https://projectusc.org/usc/t21/s364.html","content":[{"t":"sec","id":"/us/usc/t21/s364","children":[{"t":"num","text":"\u00a7\u202f364."},{"t":"heading","text":"Definitions","tail":"\n"},{"t":"chapeau","text":"In this subchapter:"},{"t":"para","id":"/us/usc/t21/s364/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"Adverse event"},{"t":"content","children":[{"t":"p","text":"The term \u201cadverse event\u201d means any health-related event associated with the use of a cosmetic product that is adverse.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s364/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Cosmetic product"},{"t":"content","children":[{"t":"p","text":"The term \u201ccosmetic product\u201d means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s364/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Facility"},{"t":"subpara","id":"/us/usc/t21/s364/3/A","children":[{"t":"num","text":"(A)"},{"t":"heading","text":"In general.\u2014"},{"t":"content","text":"The term \u201cfacility\u201d includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s364/3/B","children":[{"t":"num","text":"(B)"},{"t":"chapeau","text":" Such term does not include any of the following:"},{"t":"clause","id":"/us/usc/t21/s364/3/B/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" Beauty shops and salons, unless such establishment manufactures or processes cosmetic products at that location.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" Cosmetic product retailers, including individual sales representatives, direct sellers (as defined in ","children":[{"t":"ref","text":"section 3508(b)(2) of title 26","href":"/us/usc/t26/s3508/b/2","tail":"), retail distribution facilities, and pharmacies, unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location."}],"tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/iii","children":[{"t":"num","text":"(iii)"},{"t":"content","text":" Hospitals, physicians\u2019 offices, and health care clinics.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/iv","children":[{"t":"num","text":"(iv)"},{"t":"content","text":" Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/v","children":[{"t":"num","text":"(v)"},{"t":"content","text":" Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/vi","children":[{"t":"num","text":"(vi)"},{"t":"content","text":" Trade shows and other venues where cosmetic product samples are provided free of charge.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/vii","children":[{"t":"num","text":"(vii)"},{"t":"content","text":" 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.","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/3/B/viii","children":[{"t":"num","text":"(viii)"},{"t":"chapeau","text":" An establishment that solely performs one or more of the following with respect to cosmetic products:"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/I","children":[{"t":"num","text":"(I)"},{"t":"content","text":" Labeling.","tail":"\n"}],"tail":"\n"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/II","children":[{"t":"num","text":"(II)"},{"t":"content","text":" Relabeling.","tail":"\n"}],"tail":"\n"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/III","children":[{"t":"num","text":"(III)"},{"t":"content","text":" Packaging.","tail":"\n"}],"tail":"\n"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/IV","children":[{"t":"num","text":"(IV)"},{"t":"content","text":" Repackaging.","tail":"\n"}],"tail":"\n"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/V","children":[{"t":"num","text":"(V)"},{"t":"content","text":" Holding.","tail":"\n"}],"tail":"\n"},{"t":"subclause","id":"/us/usc/t21/s364/3/B/viii/VI","children":[{"t":"num","text":"(VI)"},{"t":"content","text":" Distributing.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s364/3/C","children":[{"t":"num","text":"(C)"},{"t":"heading","text":"Clarification.\u2014"},{"t":"content","text":"For the purposes of subparagraph (B)(viii), the terms \u201cpackaging\u201d and \u201crepackaging\u201d do not include filling a product container with a cosmetic product.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s364/4","children":[{"t":"num","text":"(4)"},{"t":"heading","text":"Responsible person"},{"t":"content","children":[{"t":"p","text":"The term \u201cresponsible person\u201d means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with ","children":[{"t":"ref","text":"section 364e(a) of this title","href":"/us/usc/t21/s364e/a","tail":" or "},{"t":"ref","text":"section 1453(a) of title 15","href":"/us/usc/t15/s1453/a","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s364/5","children":[{"t":"num","text":"(5)"},{"t":"heading","text":"Serious adverse event"},{"t":"chapeau","text":"The term \u201cserious adverse event\u201d means an adverse event that\u2014"},{"t":"subpara","id":"/us/usc/t21/s364/5/A","children":[{"t":"num","text":"(A)"},{"t":"chapeau","text":" results in\u2014"},{"t":"clause","id":"/us/usc/t21/s364/5/A/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" death;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" a life-threatening experience;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/iii","children":[{"t":"num","text":"(iii)"},{"t":"content","text":" inpatient hospitalization;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/iv","children":[{"t":"num","text":"(iv)"},{"t":"content","text":" a persistent or significant disability or incapacity;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/v","children":[{"t":"num","text":"(v)"},{"t":"content","text":" a congenital anomaly or birth defect;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/vi","children":[{"t":"num","text":"(vi)"},{"t":"content","text":" an infection; or","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s364/5/A/vii","children":[{"t":"num","text":"(vii)"},{"t":"content","text":" 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","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s364/5/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A).","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}