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Code · BILL · 116th Congress · H.R. 5279 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes. · Sec. 102

Sec. 102. Review of ingredients and nonfunctional constituents; safety of finished products

3,678 words·~17 min read·/bill/116/hr/5279/ih/section-102

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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: Not later than 3 years after the date of the enactment of the Cosmetic Safety Enhancement Act of 2019, the Secretary shall review the safety of cosmetic ingredients or nonfunctional constituents (or categories thereof). Upon the completion of such review, the Secretary shall issue an order under subsection
(d)with respect to the use of each such ingredient (or a category thereof) and presence of each such nonfunctional constituent in cosmetic products or cosmetic formulations (or a category thereof). The Secretary shall select and complete a review, on an ongoing basis, of cosmetic ingredients or nonfunctional constituents that were not reviewed in the prior 3 years. Such ingredients or nonfunctional constituents, including any classes of ingredients or nonfunctional constituents, should be selected after consultation with stakeholders, including industry and consumer groups. The Secretary shall— publish in the Federal Register a list of the ingredients, nonfunctional constituents (or categories thereof) identified for review under paragraph (2); and open a public docket to solicit public input and data relevant to the safety of the ingredients, nonfunctional constituents (or classes or categories thereof) so listed for a period of not less than 60 days. Comments may be submitted to the Secretary at any time with respect to the safety of cosmetic ingredients or nonfunctional constituents (or categories thereof), regardless of whether such ingredients or constituents (or categories thereof) have been selected for review under this subsection. The Secretary shall maintain a list, posted on the internet website of the Food and Drug Administration, of each cosmetic ingredient, nonfunctional constituent, and category of ingredients or nonfunctional constituents for which final orders have been issued under subsection (d)(3), and with respect to each such ingredient or nonfunctional constituent— the finding made for each such ingredient, nonfunctional constituent, or category under subsection (d)(4), as modified by any order under subsection (e); and if applicable, compliance dates that are the subject of a final order under subsection (d)(3). The Secretary may, at any time, propose the issuance of an order on the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof) that was not previously listed pursuant to subsection (a). Following consideration of data and comments to the public docket opened under subsection (a)(3) and any other information before the Secretary with respect to the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof), the Secretary shall— determine whether there is adequate evidence to make an initial finding for purposes of making a determination described in paragraph (4); if the Secretary determines that there is adequate evidence to make such a finding, issue a proposed administrative order containing the Secretary’s initial determination on the safety of such ingredient or nonfunctional constituent (or category thereof) as described in paragraph
(4)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; and in the case of a proposed administrative order in which the Secretary makes a determination described in subparagraph
(B)or
(C)of paragraph (4), include in such order a compliance date . The Secretary shall open a public docket for the submission of public comments (including comments on whether any proposed compliance date included in such order is feasible)— in the case of a proposed administrative order under paragraph (1), for a period of not less than 60 days, beginning on the date of the issuance of the order; or in the case of a final administrative order under paragraph (3), for a period of not less than 60 days, beginning on the date that is at least 60 days before the effective date of the order. Following the public comment period under paragraph
(2)and consideration of comments to the public docket under such paragraph and any other information before the Secretary, the Secretary shall— determine whether there is adequate evidence to make an initial finding for purposes of making a determination described in paragraph (4); if the Secretary determines that there is adequate evidence to make such a final finding, the Secretary 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; and in the case of a final administrative order in which the Secretary makes the determination described in subparagraph
(B)or
(C)of paragraph (4), include in such order a compliance date. In a proposed administrative order issued under paragraph
(1)or a final administrative order issued under paragraph (3), as applicable, the Secretary shall make a determination that the ingredient or nonfunctional constituent is— safe in cosmetic products without the need for specified conditions of use or tolerances; safe in cosmetic products under specified conditions of use or tolerances; or not safe in cosmetic products. An order under paragraph (4)(B) shall include such conditions on the use of an ingredient or such tolerances on the presence of a nonfunctional constituent (or category thereof) as are necessary for the safety of cosmetic products containing such ingredient or nonfunctional constituent (or category thereof), including— limits on the amount or concentration of the ingredient or nonfunctional constituent (or category thereof) that may be present in a cosmetic product, including limits in products intended for children, pregnant women, 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 nonfunctional constituent (or a category thereof); and such other conditions as are necessary for the safety of cosmetic products containing such ingredient or nonfunctional constituent (or category thereof). A final administrative order under this subsection shall— set forth the determination of the Secretary on safety; include a summary of the valid scientific evidence supporting the determination; include any conditions of use or tolerances under paragraph
(4)(B); and be effective upon its publication on the internet website of the Food and Drug Administration and shall be considered final agency action unless a later compliance date is otherwise specified. An order issued under subsection
(d)may be modified or revoked by the Secretary on the initiative of the Secretary or in response to a petition. If the Secretary determines that available data and information are not adequate to make a proposed or final determination under subsection (d), with respect to the safety of a cosmetic ingredient or nonfunctional constituent (or a category thereof), the Secretary shall— publish such determination on the internet website of the Food and Drug Administration not later than 180 days after the close of the relevant comment period for the ingredient or nonfunctional constituent (or category thereof) under paragraph
(2)or
(3)of subsection (d), as applicable; and include in such publication a notice providing interested persons an additional 30 days from the date on which the notice is published to provide additional data and information and an opportunity for a meeting pursuant to paragraph (2). The Secretary may offer a responsible person of such cosmetic ingredient or nonfunctional constituent (or category thereof) a confidential meeting with respect to a finding under paragraph (1), to discuss matters relating to the data and information requirements to support a determination of safety of such ingredient or nonfunctional constituent (or category thereof), which may involve confidential information. Such meeting should be convened in a reasonable time period agreed upon between the responsible person and the Secretary. If the Secretary determines that the available data and information are not adequate to make a proposed or final determination under subsection
(d)with respect to the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof), the Secretary shall— publish such finding on the internet website of the Food and Drug Administration not later than 180 days after the close of the relevant comment period for the ingredient or nonfunctional constituent (or category thereof) under paragraph
(2)or
(3)of subsection (d), as applicable; and include in such publication a notice providing interested persons an additional 30 days from the date on which the notice is published to provide additional data and information and an opportunity for a meeting pursuant to paragraph (2). If the Secretary determines, after considering any additional data and information submitted pursuant to paragraph (1)(B), that the available data and information are adequate to make a determination with respect to the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof), the Secretary shall— in the case of a determination described in subparagraph
(A)of subsection (d)(4), within 180 days of the close of the applicable comment period under subsection (d)(2), issue a final administrative order, with respect to such cosmetic ingredient or nonfunctional constituent (or category thereof), in accordance with subsection (d)(3); in the case of a determination described in subparagraph
(B)of subsection (d)(4), within 180 days of the close of the applicable comment period under subsection (d)(2), issue a proposed administrative order, followed by a final administrative order, with respect to such cosmetic ingredient or nonfunctional constituent (or category thereof), in accordance with subsection (d)(3); and in the case of a determination described in subparagraph
(C)of subsection (d)(4), within 180 days of the close of the applicable comment period under subsection (d)(2), issue a final administrative order, with respect to such cosmetic ingredient or nonfunctional constituent (or category thereof), in accordance with subsection (d)(3) specifying the date by which sale of such ingredient or nonfunctional constituent must cease. In assessing the safety of an ingredient or nonfunctional constituent (or category thereof) under this section, the Secretary shall consider— whether there is adequate evidence to support a reasonable certainty among competent scientists that— in the case of a cosmetic ingredient, the ingredient is not harmful under the recommended or suggested conditions of use or customary or usual use; or in the case of a nonfunctional constituent, that the nonfunctional constituent is not harmful under the recommended or suggested tolerance levels or the level at which it is customarily or usually present; the probable human exposure to the ingredient or nonfunctional constituent (or category thereof) from expected use in cosmetic products and cosmetic formulations; the probable cumulative and aggregate effect in humans of relevant exposure to the ingredient or nonfunctional constituent (or category thereof) 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 are available for analysis, and if appropriate, available information on the total exposure to a cosmetic ingredient or nonfunctional constituent from all sources; and whether warnings or recommendations in a cosmetic product label, as part of any conditions of use or tolerances imposed by the Secretary in a determination described in subparagraph
(B)of subsection (d)(4), would be necessary and appropriate to help ensure the safety of the ingredient or nonfunctional constituent (or category thereof). The Secretary may not consider a cosmetic ingredient or nonfunctional constituent (or category thereof) harmful under paragraph
(1)solely because it can cause minor adverse health reactions, such as minor transient allergic reactions or minor transient skin irritations, in some users. A determination that a cosmetic ingredient or nonfunctional constituent (or category thereof) is safe in cosmetics under this section shall be based upon adequate evidence submitted or otherwise known to the Secretary, which shall include full reports of all available studies, published or unpublished, that are adequately designed to show whether the ingredient or nonfunctional 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 Secretary shall consider any other relevant information related to the safety of a cosmetic ingredient or nonfunctional constituent (or category thereof), 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 nonfunctional constituent (or category thereof) is lawfully used or present in other products regulated by the Secretary, the scientific basis for such use; and experience with the ingredient or nonfunctional constituent (or category thereof) 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 nonfunctional constituent over time. In assessing for purposes of this section the safety of coal tar hair dye or any ingredient or nonfunctional constituent therein, the Secretary shall not make a determination that the dye, ingredient, or nonfunctional constituent is not safe for use in cosmetic products solely because the dye, ingredient, or nonfunctional constituent can cause allergic reactions. 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 for the customary or usual use of the product; and 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. Except as provided in subsection (c), a determination made under subsection
(a)with respect to a finished cosmetic product shall be presumed to be based on adequate evidence if it is supported by— with respect to each ingredient in the finished cosmetic 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 under such conditions of use as are customary or usual; or appropriate safety testing of the ingredient; and appropriate safety substantiation of the finished cosmetic product beyond the safety substantiation of individual ingredients and consideration of the combination of ingredients. For purposes of applying paragraph (1)(A)(i), 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 Secretary; 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 Secretary issues an order under section 608 that an ingredient or nonfunctional constituent in the finished product is not safe under the product’s conditions of use or customary or usual use; or the Secretary has provided the manufacturer with notice that— the manufacturer has not met the criteria under subsection (b); or the Secretary 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 Secretary regarding the safety of an ingredient, nonfunctional constituent, or the entire cosmetic product, and the Secretary 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 Secretary to the responsible person, be provided to the Secretary within a reasonable timeframe not to exceed 30 days, in electronic form. The Secretary may require records under paragraph
(1)if— the Secretary 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 determination required under subsection
(a)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 Secretary, 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 Secretary concludes that submission of the records will serve the public health or otherwise enable the Secretary to fulfill the cosmetic safety purposes of this section. The Secretary 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 Secretary determines that such exemptions are supported by adequate evidence and would have no adverse effect on public health. The Secretary 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. Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this subsection referred to as the Secretary ) shall convene a public meeting to describe and solicit public input regarding the ingredient review process under section 608 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). Such meeting shall include representatives from the cosmetics industry, medical practitioners and scientific experts with cosmetic expertise, and consumer and public health advocacy organizations. Not less than one year after the public meeting conducted under paragraph (1), the Secretary shall issue one or more guidance documents to implement section 608 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). Such guidance documents shall include information regarding— the types of scientific evidence, clinical studies, data, or other information needed to support the review of cosmetic ingredients or nonfunctional constituents (or categories thereof) selected for review under such section; the recommended format in which to submit to the Secretary such data and information, including any applicable foreign data and information, related to a cosmetic ingredient or nonfunctional constituent (or category thereof) that has been selected for such review; the manner and the number of days by which the Secretary intends to review and respond to such data and information, including with respect to providing a scientific rationale for any additional data and information; the process for communication between the Secretary and industry related to an ingredient or nonfunctional constituent (or a category thereof) that has been selected for review; and includes such other information as the Secretary determines appropriate. Not later than 24 months after the date of the enactment of this Act, the Secretary shall issue draft guidance under paragraph
(1)on the implementation of section 608 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes. Not later than 6 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report addressing the effectiveness and overall impact of the ingredient review program established under section 608 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), including with respect to its impact on the safety of cosmetic ingredients— for each ingredient or nonfunctional constituent (or category thereof) selected for review— whether the ingredient or nonfunctional constituent (or category thereof) was determined— to be safe in cosmetic products without the need for specified conditions of use or tolerances; to be safe in cosmetic products under specified conditions of use of tolerances; or to be not safe in cosmetic products; the timeline for such review; the types of scientific evidence, clinical studies, data, or other information used to make such a determination; whether, and to what extent, the review of the ingredient or nonfunctional constituent (or category thereof) resulted in cosmetic products being reformulated or removed from the market; and the impact the review and determination had on consumer use and access to such product; and an analysis of the ingredient, nonfunctional constituent (or category thereof) review conducted under such section 608, including— the resources used by the Secretary in reviewing ingredients and nonfunctional constituents (or categories thereof), including the effects of the program on other cosmetic safety activities of the Secretary; the impact of such section on innovation and consumer access to cosmetic products; and whether any improvements to the program under such section 608 are necessary for increasing the efficiency and effectiveness of the review of cosmetic ingredients, nonfunctional constituents, or categories thereof.
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Sec. 102
Review of ingredients and nonfunctional constituents; safety of finished products
U.S.C.§ 361
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