21 U.S.C. § 364e — Labeling

(a) General requirement: Every cosmetic product's label must include a domestic address, domestic phone number, or electronic contact, which can include a website, so the responsible person can receive adverse event reports about that product. (b) Fragrance allergens: The responsible person must list, on the label, each fragrance allergen contained in the cosmetic product. The Secretary decides by regulation which substances count as fragrance allergens for this purpose. The Secretary must propose this regulation within 18 months of December 29, 2022, and issue a final rule within 180 days after the public comment period closes. In writing this rule, the Secretary must consider international, state, and local allergen-disclosure requirements, including the European Union's approach, and may set minimum threshold amounts that trigger disclosure. (c) Cosmetic products for professional use: (1) "Professional" means someone licensed by a state authority to work in cosmetology, nail care, barbering, or esthetics. (2) A cosmetic product sold in interstate commerce and meant only for professional use must have a label that (A) clearly and prominently states it should only be given to or used by licensed professionals, and (B) otherwise meets the Secretary's normal cosmetics labeling rules under this chapter and section 1453(a) of title 15.