21 U.S.C. § 364d — Safety substantiation

Page 486 TITLE 21—FOOD AND DRUGS § 364d 1 So in original. Probably should be preceded by ‘‘subsection’’. any updates to such cosmetic product listing annually. (6) Submission A responsible person may submit product listing information as part of a facility reg- istration or separately. (d) Facility registration and product listing num- bers At the time of the initial registration of any facility under subsection (a)(1) or initial listing of any cosmetic product under (c)(1),1 the Sec- retary shall assign a facility registration num- ber to the facility and a product listing number to each cosmetic product. The Secretary shall not make such product listing number publicly available. (e) Confidentiality In response to a request under section 552 of title 5, information described in subsection (b)(2)(D) or (c)(4)(A)(i) that is derived from a reg- istration or listing under this section shall be withheld under section 552(b)(3) of title 5. (f) Suspensions (1) Suspension of registration of a facility The Secretary may suspend the registration of a facility if the Secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and the Secretary has a reasonable belief that other products manufac- tured or processed by the facility may be simi- larly affected because of a failure that cannot be isolated to a product or products, or is suf- ficiently pervasive to raise concerns about other products manufactured in the facility. (2) Notice of suspension Before suspending a facility registration under this section, the Secretary shall pro- vide— (A) notice to the facility registrant of the cosmetic product or other responsible per- son, as appropriate, of the intent to suspend the facility registration, which shall specify the basis of the determination by the Sec- retary that the facility registration should be suspended; and (B) an opportunity, within 5 business days of the notice provided under subparagraph (A), for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration. (3) Hearing on suspension The Secretary shall provide the registrant subject to an order under paragraph (1) or (2) with an opportunity for an informal hearing, to be held as soon as possible but not later than 5 business days after the issuance of the order, or such other time period agreed upon by the Secretary and the registrant, on the ac- tions required for reinstatement of registra- tion and why the registration that is subject to the suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence pre- sented, that adequate grounds do not exist to continue the suspension of the registration. (4) Post-hearing corrective action plan If, after providing opportunity for an infor- mal hearing under paragraph (3), the Sec- retary determines that the suspension of reg- istration remains necessary, the Secretary shall require the registrant to submit a cor- rective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan not later than 14 business days after the submission of the corrective ac- tion plan or such other time period as deter- mined by the Secretary, in consultation with the registrant. (5) Vacating of order; reinstatement Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions, the Secretary shall promptly vacate the suspension and reinstate the registration of the facility. (6) Effect of suspension If the registration of the facility is sus- pended under this section, no person shall in- troduce or deliver for introduction into com- merce in the United States cosmetic products from such facility. (7) No delegation The authority conferred by this section to issue an order to suspend a registration or va- cate an order of suspension shall not be dele- gated to any officer or employee other than the Commissioner. (June 25, 1938, ch. 675, § 607, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5851.) Statutory Notes and Related Subsidiaries CONSTRUCTION; CONFIDENTIALITY Nothing in section 3502 of Pub. L. 117–328, which en- acted this section, to be construed to authorize the dis- closure of information that is prohibited from disclo- sure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title. § 364d. Safety substantiation (a) Substantiation of safety A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product. (b) Coal-tar hair dye Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the require- ments of section 361(a) of this title. A respon- sible person for a coal-tar hair dye shall main- tain records related to the safety of such prod- uct. (c) Definitions For purposes of this section: (1) Adequate substantiation of safety The term ‘‘adequate substantiation of safe- ty’’ means tests or studies, research, analyses, Page 487 TITLE 21—FOOD AND DRUGS § 364f or other evidence or information that is con- sidered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe. (2) Safe The term ‘‘safe’’ means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cos- metic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cos- metic product is safe, the Secretary may con- sider, as appropriate and available, the cumu- lative or other relevant exposure to the cos- metic product, including any ingredient there- of. (June 25, 1938, ch. 675, § 608, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.) Statutory Notes and Related Subsidiaries CONSTRUCTION; CONFIDENTIALITY Nothing in section 3502 of Pub. L. 117–328, which en- acted this section, to be construed to authorize the dis- closure of information that is prohibited from disclo- sure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title. TALC-CONTAINING COSMETICS Pub. L. 117–328, div. FF, title III, § 3505, Dec. 29, 2022, 136 Stat. 5859, provided that: ‘‘The Secretary of Health and Human Services— ‘‘(1) not later than one year after the date of enact- ment of this Act [Dec. 29, 2022], shall promulgate pro- posed regulations to establish and require standard- ized testing methods for detecting and identifying as- bestos in talc-containing cosmetic products; and ‘‘(2) not later than 180 days after the date on which the public comment period on the proposed regula- tions closes, shall issue such final regulations.’’ § 364e. Labeling (a) General requirement Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event re- ports with respect to such cosmetic product. (b) Fragrance allergens The responsible person shall identify on the label of a cosmetic product each fragrance aller- gen included in such cosmetic product. Sub- stances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promul- gating the regulation implementing this re- quirement not later than 18 months after De- cember 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local re- quirements for allergen disclosure, including the substance and format of requirements in the Eu- ropean Union, and may establish threshold lev- els of amounts of substances subject to disclo- sure pursuant to such regulations. (c) Cosmetic products for professional use (1) Definition of professional For purposes of this subsection, the term ‘‘professional’’ means an individual who is li- censed by an official State authority to prac- tice in the field of cosmetology, nail care, bar- bering, or esthetics. (2) Professional use labeling A cosmetic product introduced into inter- state commerce and intended to be used only by a professional shall bear a label that— (A) contains a clear and prominent state- ment that the product shall be administered or used only by licensed professionals; and (B) is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15. (June 25, 1938, ch. 675, § 609, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5854.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–328, div. FF, title III, § 3503(b)(2), Dec. 29, 2022, 136 Stat. 5859, provided that: ‘‘Section 609(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 364e(a)], as added by section 802 [probably should be ‘‘section 3502’’], shall take effect on the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022].’’ CONSTRUCTION; CONFIDENTIALITY Nothing in section 3502 of Pub. L. 117–328, which en- acted this section, to be construed to authorize the dis- closure of information that is prohibited from disclo- sure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title. § 364f. Records (a) In general If the Secretary has a reasonable belief that a cosmetic product, including an ingredient in such cosmetic product, and any other cosmetic product that the Secretary reasonably believes is likely to be affected in a similar manner, is likely to be adulterated such that the use or ex- posure to such product presents a threat of seri- ous adverse health consequences or death to hu- mans, each responsible person and facility shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable lim- its and in a reasonable manner, to have access to and copy all records relating to such cosmetic product, and to any other cosmetic product that