Sec. 7. Identification and review of cosmetic ingredients
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Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 6, is further amended by adding at the end the following: Each year, the Secretary, in consultation with industry and consumer groups, and taking into consideration ingredients identified by a State or political subdivision as presenting a public health concern, shall identify cosmetic ingredients, as appropriate, that may present a public health concern to be reviewed for safety, including a class or classes of ingredients, or a non-functional constituent or class of non-functional constituents.
The Secretary shall publish in the Federal Register a list of the ingredients or non-functional constituents, or classes of ingredients or constituents identified for review, and solicit public input and provide the public notice and a period of 60 days to comment on any such ingredient, constituent, or class. The Secretary may identify a cosmetic ingredient or ingredients, as appropriate, to be reviewed for safety outside such annual process. If the Secretary determines that there is adequate scientific evidence to support a determination that there is reasonable certainty that an ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents is safe for use, not safe for use, or not safe for specified conditions of use, the Secretary shall post on the Internet website of the Food and Drug Administration a proposed administrative order consistent with such determination.
If the Secretary determines that there is inadequate scientific evidence to support a determination described in subparagraph (A), the Secretary shall post on the Internet website of the Food and Drug Administration such findings, together with a rationale for the findings. Nothing in this paragraph shall prevent the Secretary from considering additional scientific information or safety data related to the ingredient that is submitted to the Secretary. After allowing not less than 90 days for public comment on a proposed order under paragraph (1)(A) and a period for consideration of any such comments, if the Secretary determines that there is adequate scientific evidence to make a final determination on the safety of the applicable ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents, the Secretary shall issue a final administrative order that there is reasonable certainty that— the ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents is safe for use; the ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents is not safe for any use; or the ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents is not safe under specified conditions of use.
A final administrative order under subparagraph
(A)shall be considered final agency action for purposes of judicial review. A determination that an ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents is not safe under specified conditions of use may specify conditions of use such as— the amount or concentration of such ingredient; the populations which may specifically use such ingredient or not use such ingredient; the area of the human body on which or near which such ingredient should not be used; or such other conditions that may affect the safety of the cosmetic as a whole or in part. For purposes of this Act, including reviews for safety under this section and section 607, a cosmetic is safe if there is reasonable certainty that the cosmetic is not injurious to users under conditions of use prescribed in labeling or under such conditions of use as are customary or usual. Upon identification of a cosmetic ingredient or non-functional constituent by the Secretary under subsection (a), no State or local government may establish or continue in effect any law, regulation, order, or other requirement with respect to such ingredient or non-functional constituent, except that a State or local government may continue in effect such a requirement that was in full effect with respect to such ingredient on the date of enactment of the FDA Cosmetic Safety and Modernization Act , or that is exempted from preemption under section 752(b) of the Federal Food, Drug, and Cosmetic Act. For purposes of this Act— the term non-functional constituent means a substance or chemical, or other contaminant, that was not intentionally added or included in the formula of a cosmetic product and serves no technical purpose, but may be present as a breakdown product or by-product of manufacturing; and the term cosmetic means a cosmetic product in finished form consistent with section 201(i)(1). This section shall not be construed to affect the right of a person to lawfully market a cosmetic product that is or that contains an ingredient, class of ingredients, non-functional constituent, or class of non-functional constituents while such substance is under review or has been identified for review by the Secretary for safety. To carry out this section, there are authorized to be appropriated such sums as may be necessary. .
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Sec. 7
Identification and review of cosmetic ingredients
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