Cosmetic Supply Chain Transparency Act of 2025
- Sponsor
- Rep. Schakowsky, Janice D. [D-IL-9]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Jul 16, 2025
Bottom line
The bill aims to enhance cosmetic safety and transparency by empowering brand owners with more ingredient information and establishing a federal framework for identifying and testing harmful nonfunctional constituents, while explicitly preserving state-level protections.
What it actually does
This bill amends the Federal Food, Drug, and Cosmetic Act to mandate enhanced supply chain transparency for cosmetic ingredients. It requires suppliers to provide detailed safety and composition information to brand owners upon request and establishes a process for the FDA to create and maintain a list of 'nonfunctional constituents' known or reasonably expected to be present in cosmetics that are harmful to human health or the environment. Suppliers would then be required to test for these constituents and provide results to brand owners. The bill also explicitly preserves state authority to enact stronger cosmetic regulations.
Proponents argue
Supporters argue this bill closes critical information gaps in the cosmetic supply chain, enabling brand owners to ensure product safety and protecting consumers from harmful chemicals. They contend it empowers the FDA to proactively identify and regulate concerning substances and is crucial for consumer confidence. Furthermore, proponents highlight the importance of preserving states' ability to enact stronger protections, allowing for innovation in safety standards.
Opponents contend
Opponents might argue that the new testing and reporting requirements impose significant compliance burdens and costs on suppliers and manufacturers, potentially stifling innovation or disproportionately affecting smaller businesses. They may also contend that the FDA's existing authority, particularly under the Modernization of Cosmetics Regulation Act of 2022, is sufficient, or that a federal list based on diverse external regulations could create regulatory uncertainty and inconsistency.
The bill is relatively short but contains detailed regulatory processes and definitions that require careful reading for full comprehension. An informed reader can understand its core provisions within the given time.
Section 2(2), amending 21 U.S.C. 361 et seq. (Section 614(b))
Preservation of State Authority for Cosmetic Regulation
This provision explicitly clarifies that states are not preempted from prohibiting or limiting ingredients in cosmetic products, continuing existing state reporting requirements for ingredients, or implementing new requirements that provide greater transparency, disclosure, or protection than this Act. It also states that the Modernization of Cosmetics Regulation Act of 2022 does not preempt state action except as expressly provided in its preemption clause.
Supporters argue
Supporters argue that preserving state authority is crucial for consumer protection, allowing states to innovate and respond to emerging health concerns more quickly or comprehensively than federal processes might. This ensures that federal standards act as a floor, not a ceiling, for cosmetic safety.
Critics contend
Some industry groups might argue that a lack of federal preemption creates a complex and costly regulatory patchwork, making it difficult for companies to operate nationally. They might prefer a single, uniform federal standard to streamline compliance and reduce administrative burdens.
Tradeoffs
This provision balances the desire for a consistent national standard with the principle of federalism and the potential for states to lead on consumer safety. The tension lies between regulatory efficiency for industry and the potential for enhanced consumer protection through state action.
Section 2(3), adding Section 621 to Chapter VI of the FD&C Act
Key Definitions for Supply Chain Transparency
This section defines critical terms for the new subchapter, including 'brand owner,' 'flavor or fragrance company,' 'formulating laboratory,' 'ingredient,' 'incidental component,' 'manufacturer,' 'raw material,' and 'supplier.' Crucially, it defines 'nonfunctional constituent' as a chemical with no functional effect but present due to various factors (e.g., incidental component, manufacturing byproduct, packaging instability). It also provides a detailed definition of 'harmful to human health or the environment' by referencing specific existing state (e.g., California Prop 65) and international (e.g., EU Cosmetics Regulation, REACH, IARC) lists of toxicants, allergens, and carcinogens.
Section 2(3), adding Section 622 to Chapter VI of the FD&C Act
Mandatory Cosmetic and Ingredient Safety Information Disclosure
This section requires any supplier of a cosmetic or its ingredients to provide extensive safety and composition information to a brand owner upon request, within 90 days. This information includes functions, uses, human health and environmental hazards, physical/chemical properties, CAS Registry numbers, environmental exposure data, heavy metal testing results, safety data sheets, manufacturing flow charts, composition statements, fragrance allergen statements, IFRA conformity certificates, and a full listing of ingredients (including those in fragrance/flavor formulations) in descending order of predominance by weight.
Section 2(3), adding Section 623 to Chapter VI of the FD&C Act
FDA List of Harmful Nonfunctional Constituents
This section directs the FDA Secretary to create and maintain a list of 'nonfunctional constituents' that are known or reasonably expected to be present in cosmetics or ingredients and are 'harmful to human health or the environment' (as defined in Section 621). The Secretary must identify the specific ingredients or cosmetics where these constituents are expected. An initial list must be finalized within 18 months after public comment and advice from an advisory committee (composed of industry, nonprofit, scientific, medical, and public health representatives). The list will be reviewed and updated annually, including through a petition process for adding new constituents or reference lists.
Section 2(3), adding Section 624 to Chapter VI of the FD&C Act
Testing and Reporting of Nonfunctional Constituents
This section mandates that suppliers of ingredients or cosmetics must conduct testing for any nonfunctional constituent added to the FDA's list (established under Section 623) within one year of its addition. Prior to selling the ingredient or cosmetic to a brand owner, the supplier must provide a certificate of analysis. This certificate must include the levels of each nonfunctional constituent present, the analytical tests used, their detection limits, and heavy metal testing results.
Section 2(3), adding Section 625 to Chapter VI of the FD&C Act
Supply Chain Information for Adulterated/Misbranded Cosmetics
This section grants the FDA Secretary authority to request supply chain information when there is reason to believe a cosmetic is adulterated, misbranded, or violates the Act. The Secretary can request from the brand owner the names and places of business of the cosmetic's manufacturer and any ingredient suppliers, as well as any entities (including retailers) to whom the brand owner provided the cosmetic. The Secretary can also request similar information from any other entity in the supply chain. All entities in the supply chain are required to maintain records sufficient to provide this information and must provide it upon request.
Section 2(3), adding Section 626 to Chapter VI of the FD&C Act
Civil Penalties for Non-Compliance
This section establishes civil penalties for violations of the new transparency and testing requirements. Any person who violates Section 622 (Cosmetic and Ingredient Safety Information), Section 624 (Treatment of Nonfunctional Constituents), or Section 625 (Notification, Nondistribution, and Recall) shall be liable for a civil penalty of up to $10,000 for each day the violation continues.
The bill defines 'harmful to human health or the environment' by directly referencing eight specific external lists of chemicals. These lists include California's Safe Drinking Water and Toxic Enforcement Act (Prop 65), EPA's Toxics Release Inventory for PBTs, various European Union Cosmetics Regulations (Annex II, Annex III), the EU REACH Regulation for Substances of Very High Concern (SVHC) and carcinogens/mutagens/reproductive toxicants, and Group 1, 2A, or 2B carcinogens identified by the International Agency for Research on Cancer (IARC). It also allows the Secretary to add 'any other list the Secretary determines appropriate'.
Section 2(3), adding Section 621(4) to Chapter VI of the FD&C Act
Why it matters:Leveraging existing, well-established lists is a standard legislative practice to avoid reinventing the wheel and to tap into existing scientific consensus. However, it also means the full scope of substances deemed 'harmful' under this bill is not immediately apparent without consulting multiple external documents.
Case for: Supporters argue that incorporating these widely recognized and scientifically vetted lists streamlines the process for the FDA, avoids redundant scientific review, and immediately brings the bill's scope in line with leading chemical safety regulations globally and domestically. This approach provides a strong, pre-existing foundation for identifying harmful substances.
Case against: Critics might contend that relying so heavily on external lists, particularly international ones, could lead to the inclusion of substances without a thorough, independent review specific to U.S. cosmetic applications. It could also create regulatory instability if those underlying lists are updated or if their criteria differ from what might be preferred for federal U.S. law.
Estimated impact: This provision significantly expands the universe of chemicals that will be subject to testing and reporting requirements under the bill, potentially encompassing hundreds or thousands of substances already identified as concerning by other regulatory bodies.