H.R. 4434

119th CONGRESS 1st Session

To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cosmetics, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES · July 16, 2025 · Sponsor: Ms. Schakowsky · Committee: Committee on Energy and Commerce

Table of contents

• H.R. 4434
  • SEC. 1. Short title
  • SEC. 2. Cosmetic regulation

SEC. 1. Short title

• This Act may be cited as the Cosmetic Supply Chain Transparency Act of 2025.

SEC. 2. Cosmetic regulation

• Chapter VI of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 361 et seq.
  • by inserting before section 601 the following:
    • (b) Limitations
      • (1) In general
        • Notwithstanding subsection (a), nothing in this section shall be construed to prevent any State (or a political subdivision thereof) from—
          • prohibiting the use or limiting the amount of an ingredient in a cosmetic product;
          • continuing to implement a requirement of such State (or a political subdivision thereof) that is in effect at the time of enactment of the Modernization of Cosmetics Regulation Act of 2022 for the reporting to the State (or a political subdivision thereof) of an ingredient in a cosmetic product; and
          • implementing a requirement of such State (or a political subdivision thereof), or continuing to implement a requirement that is in effect at the time of enactment of the , that provides greater transparency, disclosure, or protection than the amendments made by such Act, with respect to—
            • (i) cosmetic ingredients;
            • (ii) the practices used in the manufacture of cosmetics (and the ingredients thereof); or
            • (iii) the disclosure of information with respect to such ingredients or such practices.
      • (2) Modernization of Cosmetics Regulation Act of 2022
        • Nothing in the amendments to this Act made by the Modernization of Cosmetics Regulation Act of 2022 shall be construed to preempt any State statute, public initiative, referendum, regulation, or other State action, except as expressly provided in subsection (a).
  • in section 614, by amending subsection (b) to read as follows:
    • In this subchapter:
      • The term brand owner means the entity responsible for bringing a cosmetic to market.
      • The term flavor or fragrance company means an entity that makes or supplies fragrance or flavor ingredients or fragrance or flavor formulations.
      • The term formulating laboratory means an entity that supplies a finished cosmetic product to a retailer or cosmetic company to sell under the retailer or cosmetic company’s brand name.
      • The phrase means, with respect to a nonfunctional constituent— harmful to human health or the environment
      • The term ingredient means an intentionally added chemical in a cosmetic that has a technical or functional effect, including—
      • The term incidental component means—
      • The term manufacturer means any entity that—
      • The term nonfunctional constituent means a chemical that has no functional or technical effect on the product or ingredient and is present—
      • The term raw material means a substance or mixture of substances that—
      • The term — supplier
    • At the request of a brand owner of a cosmetic, a supplier of the cosmetic or any ingredient therein shall, not later than 90 days after receipt of such request, provide to the brand owner, with respect to the cosmetic or ingredient, any of the following information:
    • (1)
      • Functions and uses.
      • The human health and environmental hazards.
      • The physical and chemical properties.
      • The Chemical Abstracts Services Registry number of any such ingredient.
      • Environmental exposure and fate information.
      • Heavy metal testing results.
      • Safety data sheets.
      • Manufacturing flow charts.
      • Composition statement.
      • Fragrance allergen statement.
      • International Fragrance Association (IFRA) standards conformity certificate.
      • Any other information used to substantiate the safety of such ingredient.
      • A full and complete listing of ingredients in fragrance or flavor formulations, preservative systems, or other ingredient formulations, including the presence of any allergens.
      • A full and complete listing of ingredients in a finished cosmetic presented in descending order of predominance by weight, except that ingredients present in amounts of 1 percent or less by weight can be placed in any order at the end of the ingredient statement.
      • A certificate of analysis for the ingredient.
    • (a) In general
      • The Secretary shall create and maintain a list of nonfunctional constituents to guide testing under this subchapter conducted by suppliers of cosmetics and ingredients.
    • (b) Contents
      • The list under subsection (a) shall consist of nonfunctional constituents that are—
        • known or reasonably expected to be present in cosmetics or ingredients; and
        • subject to subsection (e)(2), harmful to human health or the environment.
    • (c) Identification of ingredients and cosmetics
      • For each nonfunctional constituent on the list under subsection (a), the Secretary shall identify the specific ingredient or cosmetic, or category of ingredients or cosmetics, in which the nonfunctional constituent is known or reasonably expected to be present.
    • (d) Initial list
      • (1) In general
        • In creating the initial list under subsection (a), the Secretary shall—
          • publish a proposed list and provide an opportunity for public comment on such proposed list for a period of 60 days; and
          • not later than 18 months after the date of enactment of the , finalize and publish the list.
      • (2) Advisory committee
        • (A) In general
          • Not later than 9 months after the date of enactment of the , the Secretary shall convene an advisory committee to advise the Secretary on—
            • (i) creating the initial list under subsection (a); and
            • (ii) best practices related to analytical testing for nonfunctional constituents in cosmetics and ingredients.
        • (B) Membership
          • The membership of the advisory committee convened under subparagraph (A) shall consist of an equal number of—
            • (i) representatives from industry;
            • (ii) representatives from the nonprofit community;
            • (iii) representatives from the scientific community; and
            • (iv) representatives from the medical and public health community.
        • (C) Termination
          • The Secretary shall terminate the advisory committee convened under this paragraph upon the finalization of the initial list pursuant to paragraph (1).
    • (e) Updates
      • Not less than annually after the finalization pursuant to subsection (d) of the initial list under subsection (a), and not less than annually thereafter, the Secretary shall—
        • review the list under subsection (a);
        • after providing a period of at least 30 days for public comment, update the list by adding nonfunctional constituents that are known or reasonably expected to be present in a cosmetic or ingredient as specified in subsection (b)(1) and—
          • are determined by the Secretary to meet the standard specified in section 621(4)(A) based on existing and emerging science; or
          • have been added to one of the lists in section 621(4)(B); and
        • update the list by adding any nonfunctional constituent whose addition was approved pursuant to a petition under subsection (f).
    • (f) Petition process for adding nonfunctional constituents or new lists
      • (1) In general
        • Any person may petition, in accordance with paragraph (3), to add—
          • a nonfunctional constituent to the list under subsection (a); or
          • a new list to the lists specified in section 621(4)(B).
      • (2) Development of process
        • The Secretary—
          • not later than 24 months after the date of enactment of the , shall develop and publish the process for submitting a petition under this subsection; and
          • may periodically review and update such process.
      • (3) Requirements for process
        • The process developed and updated by the Secretary under paragraph (2) shall be consistent with the following:
          • Such process shall specify the necessary scientific justification that must be included in a petition.
          • The Secretary shall—
            • (i) provide a 30-day period for public comment on a petition; and
            • (ii) not later than 90 days after the close of such public comment period, approve or deny the petition.
          • If the Secretary approves a petition, the Secretary shall provide notice in the Federal Register of each addition made pursuant to such approval.
          • In denying a petition, the Secretary shall provide a written justification to the petitioner for the denial.
    • (g) Guidance
      • The Secretary—
        • shall, concurrently with the publication of the initial list under subsection (a), and upon adding any nonfunctional constituent pursuant to subsection (e) or (f) to the list under subsection (a), issue guidance for industry on best practices related to—
          • analytical testing for nonfunctional constituents in cosmetics and ingredients; and
          • detection limits; and
        • may periodically review and update such guidance.
    • A supplier of an ingredient or cosmetic shall—
      • not later than 1 year after a nonfunctional constituent is added to the list under section 623(a) pursuant to subsection (d), (e), or (f) of section 623, conduct testing for such nonfunctional constituent; and
      • prior to the sale of the ingredient or cosmetic to the brand owner, provide the brand owner a certificate of analysis that includes—
        • the levels of each such nonfunctional constituent present;
        • any analytical test used;
        • the detection limits of any analytical test used to detect each such nonfunctional constituent; and
        • heavy metal testing results.
    • (a) Supply chain information
      • In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, the Secretary shall request that the brand owner named on the label of such cosmetic submit to the Secretary all of the following information:
        • The name and place of business of the manufacturer of the cosmetic and any supplier of an ingredient or raw material used in the manufacture of the cosmetic.
        • The name and place of business of any entity (including any retailer) to which the brand owner provided the cosmetic.
    • (b) Collection of additional supply chain information
      • In the case of a cosmetic that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act, to the extent necessary to protect the safety of the public, the Secretary may request that any entity in the supply chain of such cosmetic submit to the Secretary information that is similar to the information described in paragraphs (1) and (2) of subsection (a).
    • (c) Maintenance of records
      • Any entity in the supply chain of a cosmetic (including the brand owner named on the label of a cosmetic) shall—
        • maintain records sufficient to provide the information described in paragraphs (1) and (2) of subsection (a); and
        • provide such information to the Secretary upon the request of the Secretary.
    • Any person that violates section 622, 624, or 625 shall be liable to the United States for a civil penalty in an amount up to $10,000 for each day on which such violation continues.
  • by adding at the end the following: