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

(a) Substantiation of safety: The responsible person for a cosmetic product must make sure there is adequate proof the product is safe, and must keep records supporting that proof. (b) Coal-tar hair dye: Subsection (a) does not apply to coal-tar hair dye that otherwise follows section 361(a)'s rules. But the responsible person for that hair dye must still keep safety-related records. (c) Definitions: (1) "Adequate substantiation of safety" means tests, studies, research, analyses, or other evidence that qualified experts consider enough to reasonably support that a cosmetic product is safe. (2) "Safe" means the cosmetic, including any ingredient, does not hurt users under the conditions listed on its label, or under normal, expected use. The Secretary cannot call a cosmetic or ingredient harmful just because it can cause minor, temporary reactions or skin irritation in some users. When deciding if a product is safe, the Secretary may consider, as appropriate and available, cumulative or other relevant exposure to the product, including its ingredients.