21 U.S.C. § 364e — Labeling

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