; or (2) where the cost of compliance exceeds the safety benefit to the public. . (b) Cosmetic definition Section 201(i) ( 21 U.S.C. 321(i) ) is amended by adding at the end the following: An article described in subparagraph (1) that is intended only for topical external use to alter the appearance by temporarily affecting the structure or any function of the human skin, and that is not the subject of an approved new drug application under section 505, shall, for purposes of this Act, be treated only as a cosmetic and not a drug. . (c) Color Additives Section 721(f) ( 21 U.S.C. 379e(f) ) is amended— (1) by striking (f) The Secretary shall and inserting (f)(1) The Secretary shall