For years, consumers have taken legal action against cosmetic companies, alleging a link between talc-based products and cancer, particularly mesothelioma and ovarian cancer. The litigation has produced varied outcomes, but concerns over asbestos contamination in talc persist.
In response, the U.S. Food and Drug Administration (FDA) has introduced a proposed rule to enforce standardized asbestos testing in talc-containing cosmetics. This move aligns with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and aims to ensure consumer safety. The rule, if finalized, will significantly impact cosmetic manufacturers and ongoing consumer lawsuits.
Key Details of FDA’s Proposed Rule
Publication and Legal Standing
On December 27, 2024, the FDA published the proposed rule in the Federal Register. While an Executive Order signed on January 20, 2025, by President Donald Trump required agencies to review pending regulations, this rule had already been published and is legally required under MoCRA. Therefore, it cannot be withdrawn but may face potential delays.
Although the rule lacks an official effective date, federal agencies are encouraged to postpone implementation by 60 days, allowing for further industry input. However, due to MoCRA’s statutory mandate, the FDA must proceed with finalizing the rule.
Why Asbestos Testing for Talc-Containing Cosmetics?
Talc is widely used in cosmetics such as baby powder, face powders, blush, foundation, and eyeshadow. It is a naturally occurring mineral often found in proximity to asbestos, a known carcinogen. Since asbestos contamination can occur during mining, ensuring that talc-based products remain asbestos-free is crucial for consumer health.
FDA cited studies indicating that asbestos may be inseparable from talc in its natural state, raising concerns about contamination risks. The proposed rule aims to establish consistent testing methods to detect asbestos before these products reach the market.
Who Must Comply with the New Testing Requirements?
The rule applies to all manufacturers of talc-containing cosmetics, including those classified as both cosmetics and drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
What Are the New Testing Standards?
Under the proposed rule, manufacturers must:
- Test a representative sample of each batch or lot of talc-containing cosmetic products
- Alternatively, test the raw talc ingredient before product formulation
Testing must utilize both:
- Polarized Light Microscopy (PLM) with dispersion staining
- Transmission Electron Microscopy (TEM) coupled with Energy Dispersive Spectroscopy (EDS) and Selected Area Electron Diffraction (SAED)
If asbestos is detected through either method, the sample will be considered contaminated.
Supplier Certification as an Alternative
Instead of direct testing, manufacturers may rely on a certificate of analysis from their talc suppliers. However, they must ensure that the supplier’s testing includes both PLM and TEM/EDS/SAED methods and that testing is performed annually on the specific talc used.
Recordkeeping and Retention Requirements
The FDA’s proposed rule imposes strict recordkeeping requirements:
- Manufacturers must maintain asbestos test results, raw data, and detailed sampling descriptions.
- If relying on a supplier’s certificate, companies must retain these documents and verify supplier compliance.
- All records must be preserved for three years and be readily available for FDA inspection.
- Documents must be accessible within one business day upon FDA request, including electronic submissions.
Enforcement and Compliance Risks
Under the proposed rule, a cosmetic product will be deemed adulterated if:
- Any amount of asbestos is detected in either the final product or raw talc.
- Manufacturers fail to comply with testing or recordkeeping requirements.
Selling or distributing an adulterated product violates both the FD&C Act and MoCRA. Additionally, the FDA gains authority to recall any contaminated cosmetics under MoCRA’s enforcement provisions.
Industry Response and Public Comment Period
FDA is inviting public comments on the proposed rule until March 27, 2025, at 11:59 p.m. Eastern Time. Stakeholders, including manufacturers and industry groups, can submit feedback electronically via www.regulations.gov or by mail.
FDA specifically seeks input on:
- The feasibility of the proposed testing methods
- Existing industry practices for talc testing
- Recordkeeping burdens and associated costs
- Potential economic impacts on cosmetic companies
Industry stakeholders should actively participate in the comment process to shape the final rule’s requirements.
Impact on Consumer Litigation
New Industry Testing Standards
If finalized, the rule will establish clear standards for asbestos testing in talc-based products. This could impact consumer lawsuits in several ways:
- Plaintiffs relying on different testing methods may face challenges in court.
- Companies adhering to FDA’s rule may argue that compliance confirms their products are asbestos-free but that doesn’t mean products in past years were asbestos-free.
Increased Discovery Demands in Litigation
The recordkeeping requirements may lead to:
- Increased discovery requests from plaintiffs seeking historical test data and supplier certifications.
- The need for manufacturers to demonstrate continuous compliance with FDA’s final rule.
Compliance as a Legal Defense
Corporations will no doubt contend that adherence to FDA regulations could serve as a compliance defense in litigation. However, products liability laws may not hinge on following testing standards and liability could still be found – particularly for past decades of making asbestos containing talc products. .
What’s Next for the FDA’s Proposed Rule?
As the public comment period progresses, industry and consumer feedback will shape the final version of the rule. While delays are possible, MoCRA requires the FDA to implement a standardized asbestos testing framework for talc in cosmetics.
The FDA’s proposed rule marks a significant step toward ensuring consumer safety by addressing asbestos risks in talc-containing cosmetics.
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