; or (B) requiring, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). (2) The term unexpected , with respect to an adverse event, means not identified on the cosmetic label. . (b) Misbranding Section 602 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 362 ) is amended by adding at the end the following: (g) If it is a cosmetic that is marketed in the United States, unless the label of such cosmetic includes a domestic address or domestic phone number through which a report of a serious and unexpected adverse event (as such term is used in section 607) associated with the use of such cosmetic may be submitted to the person described in section 607(f). . 7. Good manufacturing practice (a) Prohibition Section 601 ( 21 U.S.C. 361 ) is amended by adding at the end the following: (f) If it has been manufactured under conditions that do not satisfy the principles and standards for good manufacturing practice established under section 608 and as a result presents a significant risk of serious adverse health consequences or death to humans. . (b) Principles and standards Chapter VI ( 21 U.S.C. 361 et seq.), as amended by sections 3, 4, 5, and 6, is further amended by adding at the end the following: 608. Good manufacturing practice (a) In general The Secretary may by regulation establish principles and standards for good manufacturing practice for the manufacture of cosmetics in accordance with paragraphs (a) and (d) of section 601. (b) Notice and comment A regulation under subsection (a) shall be promulgated only after providing notice and an opportunity for comment in accordance with chapter 5 of title 5, United States Code. (c) Good manufacturing practices of other parties A manufacturer shall not be responsible under section 601(f) or this section for the good manufacturing practice of its suppliers. A distributor shall not be responsible under section 601(f) or this section for the good manufacturing practice of its manufacturers.