Sec. 102. Review of ingredients and non-functional constituents; safety of finished products
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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 101, is further amended by adding at the end the following: Beginning in fiscal year 2016, the Food and Drug Administration shall review the safety of the cosmetic ingredients and non-functional constituents under paragraph (3), as modified under subsection (c), if applicable, and issue an order under subsection
(d)with respect to the use of each such ingredient and presence of each such non-functional constituent. At the initiation of the review of each cosmetic ingredient or non-functional constituent, the Food and Drug Administration shall open a docket for the submission of public comment and additional data relevant to the safety of the ingredient or non-functional constituent. The Food and Drug Administration shall provide 60 days for public comment. During fiscal year 2016, the Food and Drug Administration shall initiate the review for safety of the following cosmetic ingredients: Diazolidinyl urea. Lead acetate. Methylene glycol/methanediol/formaldehyde. Propyl paraben. Quaternium-15. Beginning in fiscal year 2017, the Food and Drug Administration shall annually select and complete a review of at least 5 cosmetic ingredients or non-functional constituents that were not reviewed in the prior 3 years from a list determined in consultation with industry and consumer groups for review of safety. The Food and Drug Administration may modify such list under subsection (c). The determination of which ingredients or functional ingredients will be reviewed in a given year shall be publicized in annual reports to Congress and the public, in accordance with section 618, and subject to consultation as provided for in clause (iii). The review of any cosmetic ingredient or non-functional constituent shall commence with a public announcement by the Food and Drug Administration and the opening of a docket as required under paragraph (2). The Food and Drug Administration shall establish a Cosmetics Safety Advisory Committee, which shall include equal numbers of individuals from the cosmetics industry and consumer groups, and other individuals, as the Food and Drug Administration determines appropriate, including medical practitioners. Such advisory committee shall advise the Food and Drug Administration on cosmetic ingredients and non-functional constituents to be considered for review, summarize public comments received pursuant to paragraph (4), and recommend 5 cosmetic ingredients or non-functional constituents to be reviewed for safety each year, as described in clause (i). The Food and Drug Administration may consult with the Cosmetics Safety Advisory Committee on other matters pertaining to cosmetic safety. As part of the annual reporting to Congress and the public under section 618, the Food and Drug Administration shall solicit public comment on which cosmetic ingredients or non-functional constituents on the list are of greatest interest to be reviewed next for early review and which additional cosmetic ingredients or non-functional constituents should be added to the list. The public may submit comments to the Food and Drug Administration at any time during the year regarding which cosmetic ingredients or non-functional constituents of interest that the Food and Drug Administration may consider during that year or subsequent years. The Food and Drug Administration shall maintain a list, posted on the Internet website of the Food and Drug Administration, of the cosmetic ingredients and non-functional constituents for which final orders have been issued under subsection (d)(3), the finding made for each such ingredient or non-functional constituent under subsection (d)(4), as modified by any order under subsection (f), and, if applicable, compliance dates that are the subject of a final order under subsection (e). The Food and Drug Administration may at any time, after consultation with the Cosmetics Safety Advisory Committee, propose the issuance of an order on the safety of a cosmetic ingredient or non-functional constituent that was not previously listed in subsection
(a)or under section 618(a)(3). Following consideration of data and comments to the public docket and any other information before the Food and Drug Administration, the Food and Drug Administration shall determine whether there is adequate evidence to make an initial finding on the safety of the ingredient or non-functional constituent. If the Food and Drug Administration determines that there is adequate evidence, the Food and Drug Administration shall issue a proposed administrative order and shall post such order on the Internet website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 of title 5, United States Code. Upon publication of the proposed administrative order described in paragraph (1), the Food and Drug Administration shall open a docket for the submission of public comment. The Food and Drug Administration shall provide 30 days for public comment following publication of the proposed administrative order. Following the public comment period described in paragraph
(2)and consideration of comments to the public docket and any other information before the Food and Drug Administration, the Food and Drug Administration shall determine whether there is adequate evidence to make a final finding on the safety of the ingredient or non-functional constituent. If the Food and Drug Administration determines that there is adequate evidence, the Food and Drug Administration shall issue a final administrative order and shall post such order on the Internet website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 of title 5, United States Code. In the proposed administrative order or the final administrative order, as applicable, the Food and Drug Administration shall make a determination that the ingredient or non-functional constituent is— safe in cosmetic products under specified conditions of use or tolerances; safe in cosmetic products without the need for specified conditions of use or tolerances; or not safe in cosmetic products. An order under paragraph (4)(A) shall include such conditions on the use of an ingredient or such tolerances on the presence of a non-functional constituent as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent, including— limits on the amount or concentration of the ingredient or non-functional constituent that may be present in a cosmetic product, including limits in products intended for children and other vulnerable populations, and limits on use near the eye or mucosal membranes; warnings that are necessary or appropriate under section 614, including warnings related to use by children, pregnant women, populations with high exposure to the ingredient (such as workers who are exposed through production practices or handling of final products), or other vulnerable populations, to help ensure safe use of cosmetic products containing the ingredient or non-functional constituent; and such other conditions as are necessary for the safety of cosmetic products containing such ingredient or non-functional constituent. A final order under this subsection shall set forth the determination of the Food and Drug Administration on safety, any conditions of use or tolerances under subparagraph
(A)or
(B)of paragraph
(4)and a summary of the valid scientific evidence supporting the finding. The order shall be effective upon its publication on the Internet website of the Food and Drug Administration and shall be considered final agency action. If the Food and Drug Administration issues a final administrative order under subparagraph
(A)or
(C)of subsection (d)(4), the Food and Drug Administration shall, at the same time as publication of the notice under subsection (d)(6), publish a proposed order identifying dates by which use of the ingredient or non-functional constituent in cosmetic products shall comply with the final administrative order, and provide 60 days for public comment, including comment on whether compliance is feasible within the proposed dates. After considering comments on the proposed order, the Food and Drug Administration shall publish in the Federal Register a final order. An order issued under subsection
(d)or
(e)may be modified or revoked by the Food and Drug Administration on the initiative of the Food and Drug Administration or in response to a petition. If the Food and Drug Administration determines that the available data and information are not adequate to make a proposed or final determination regarding safety under subsection (d)(4), with respect to a cosmetic ingredient or non-functional constituent, the Food and Drug Administration shall— publish such finding on the Internet website of the Food and Drug Administration not later than 90 days after the close of the relevant comment period for the ingredient or non-functional constituent under subsection (a)(2), in the case of a proposed order, or subsection (d)(2), in the case of a final order; and include a notice providing interested persons an additional 30 days from the notice date to provide additional data and information; and if, after the 30-day period under clause (i), the Food and Drug Administration determines that additional safety substantiation with respect to such ingredient or non-functional constituent is necessary to make a safety determination, include a notice specifying an additional time period, not to exceed 18 months from the notice date, and plan to obtain such data and information. If the Food and Drug Administration determines, after considering any additional data and information submitted under paragraph (1)(B), that the available data and information still are not adequate to make a determination regarding safety under subsection (d)(4), the Food and Drug Administration shall, within 90 days of the close of the additional time period provided under paragraph (1)(B), issue a proposed order or a final administrative order— making a determination that the ingredient or non-functional constituent has not been shown to be safe in cosmetic products; and explaining why the available data and information are not adequate to assess the safety of the ingredient or non-functional constituent. If the Food and Drug Administration determines, after considering any additional data and information submitted under paragraph (1)(B), that the available data and information are adequate to make a determination regarding safety under subsection (d)(4), the Food and Drug Administration shall, within 180 days of the close of the comment period, issue a proposed order, followed by a final order, on such cosmetic ingredient or non-functional constituent, in accordance with such subsection. In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider whether there is adequate evidence to support a reasonable certainty among competent scientists that the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use, or that a non-functional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present. The Food and Drug Administration may not consider an ingredient or non-functional constituent harmful solely because it can cause minor adverse health reactions, such as minor transient allergic reactions or minor transient skin irritations, in some users. In assessing the safety of an ingredient or non-functional constituent, the Food and Drug Administration shall consider, among other relevant factors, the following: The probable human exposure to the ingredient or non-functional constituent from expected use in cosmetics. The probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or non-functional constituent or to any chemically or pharmacologically related substances from use in cosmetics or other products with similar routes of exposure under recommended or suggested conditions of use or their customary use, to the extent adequate data is available for analysis. In appropriate cases, the Food and Drug Administration may consider available information on the total exposure to an ingredient or non-functional constituent from all sources. Whether warnings or recommendations in a product label, as part of any conditions of use or tolerances imposed by the Food and Drug Administration, would be necessary and appropriate to help ensure the safety of the ingredient or non-functional constituent. A determination that an ingredient or non-functional constituent is safe in cosmetics shall be based upon adequate evidence submitted or otherwise known to the Food and Drug Administration, which shall include full reports of all available studies, published or unpublished, that are adequately designed to show whether the ingredient or non-functional constituent is safe. Such studies may include in vitro and in silico studies and epidemiological studies, biomonitoring studies, and studies focused on various points during the lifespan of the subject, that use scientifically valid methodology. The Food and Drug Administration shall consider any other relevant information related to the safety of the ingredient or non-functional constituent, including— adverse event reports; findings and information from State, Federal, national, and international entities and other bodies composed of scientific and medical experts; if the ingredient or non-functional constituent is lawfully used or present in other products regulated by the Food and Drug Administration, the scientific basis for such use; and experience with the ingredient or non-functional constituent in products that are distributed in the United States or in other countries, if such experience is well-documented and has resulted in substantial human exposure to the ingredient or non-functional constituent over time. . Each responsible person for a finished cosmetic product shall, before first distributing the product for sale, make a written determination that the product is safe under the conditions of use recommended in the labeling of the product. Such determination shall be based on adequate evidence that each ingredient in the finished product is safe for the use recommended or suggested in the labeling of the product and that the finished product is safe. If new information relevant to the determination becomes available, the responsible person shall promptly update the determination to address that information. In the case of a cosmetic product for which there is a range of possible amounts of cosmetic ingredients included in the cosmetic ingredient statement, as described in section 606(c)(2)(E), the safety determination under paragraph
(1)shall include substantiation of the safety of the full range in the finished product. Except as provided in subsection (c), a determination made under subsection
(a)shall be presumed to be based on adequate evidence if it is supported by— with respect to each ingredient in the finished product— references to an official statement by one or more expert medical or scientific bodies that the ingredient is safe under the conditions of use recommended or suggested in the product’s labeling; or appropriate safety testing of the ingredient; and appropriate safety substantiation of the finished product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients. For purposes of this section, a statement of an expert medical or scientific body is an official statement of that body, if— the medical or scientific body is a Federal, State, national, or international entity with recognized expertise in chemical or cosmetic safety, or other similarly recognized body composed of scientific and medical experts; the statement is based upon adequate data to support the finding of safety, and such data are available to the Food and Drug Administration; and the statement is published and endorsed by the medical or scientific body and is not a statement of an employee of such body made in the individual capacity of the employee. Notwithstanding subsection (b), a determination under subsection
(a)will not be presumed to be based on adequate evidence if— the Food and Drug Administration issues an order under section 608 that an ingredient or non-functional constituent in the finished product is not safe under the product’s conditions of use or customary or usual use; or the Food and Drug Administration has provided the manufacturer with notice that— the manufacturer has not met the criteria under subsection (b); or the Food and Drug Administration has information that raises significant questions about the safety of the product or any of its ingredients. Upon notice of inadequate evidence under subsection (c), the responsible person shall have 10 days to submit additional evidence to the Food and Drug Administration regarding the safety of an ingredient, non-functional constituent, or the entire cosmetic product, and the Food and Drug Administration shall have 30 days from the date of receipt of such additional evidence to provide the responsible person with notice that the criteria under subsection
(b)have been met or not met. The responsible person shall maintain records documenting the determination required under this section and the information on which it is based until 5 years after the finished product is no longer marketed. The records required under subsection
(e)shall, upon the written request of the Food and Drug Administration to the responsible person, be provided to the Food and Drug Administration within a reasonable timeframe not to exceed 60 days, in either electronic or paper form. The Food and Drug Administration may require records under paragraph
(1)if— the Food and Drug Administration has a reasonable belief, described in written notice, that— the finished product may be harmful based on adverse event reports or other scientific information; scientific information raises credible and relevant questions about the safety of the product or any of its ingredients; the responsible person has not made the determination required under subsection (a), or such determination is not supported by adequate evidence; or one or more of the criteria to establish a presumption of adequate evidence of safety in subsection
(b)has not been satisfied; the Food and Drug Administration, an expert regulatory body, or an expert body composed of scientific and medical experts finds an ingredient in the product to be unsafe under the conditions of use of the product; or the Food and Drug Administration concludes that submission of the records will serve the public health or otherwise enable the Food and Drug Administration to fulfill the cosmetic safety purposes of this section. The Food and Drug Administration shall issue guidance describing the evidence necessary to support a determination under subsection (a), and may, by regulation, establish exemptions to the requirements of this section, if the Food and Drug Administration determines that such exemptions are supported by adequate evidence and would have no adverse effect on public health. The Food and Drug Administration shall, after consultation with the Small Business Administration and small businesses that manufacture cosmetics, provide additional guidance for small businesses on compliance with the requirements of this section. Such guidance shall include specific examples of options for compliance that do not place an undue burden on small businesses. . Section 609 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall take effect 180 days after the date of enactment of this Act.
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Sec. 102
Review of ingredients and non-functional constituents; safety of finished products
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