As the U.S. continues to strengthen its regulatory framework under the Modernization of Cosmetics Regulation Act (MoCRA), the FDA has published a proposed rule that could significantly impact cosmetics containing talc.
A New Testing Requirement for Manufacturers
On December 26, 2024, the FDA proposed the introduction of standardized testing methods to detect the presence of asbestos in talc-containing cosmetic products. The proposed rule would require manufacturers to test their products using validated techniques such as:
- PLM (Polarized Light Microscopy)
- TEM/EDS/SAED (Transmission Electron Microscopy / Energy Dispersive Spectroscopy / Selected Area Electron Diffraction)
These methods were reviewed and supported by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) in a peer-reviewed scientific report published in 2022.
Why Is This Change Important?
Asbestos is a known human carcinogen, and while not intentionally added to cosmetics, it can be a natural contaminant in talc, commonly used in powders and makeup products.
Until now, no specific method has been officially required in the U.S. to test for asbestos in cosmetics. This proposal aims to harmonize testing practices and enhance consumer safety.
What Will Be Required If the Rule Is Finalized?
- Batch or representative sample testing of talc-containing cosmetic products.
- Option to rely on a supplier certificate of analysis, subject to verification testing.
- Enforcement provisions: Products failing to comply would be deemed adulterated under the FD&C Act.
- Obligations to retain documentation and demonstrate traceability.
- Products found to contain asbestos would be removed from the market, with potential penalties for non-compliant manufacturers.
A Positive Signal for Responsible Brands
Beyond the critical health concern, this regulation provides clarity and an opportunity for responsible brands to prove their product safety rigor. Fewer recalls, streamlined compliance, and greater consumer trust are all direct benefits.
Comment Period Now Open
👉 The proposed rule is now open for public comment for 90 days via Regulations.gov, referencing docket number FDA-2023-N-4225.
🔍 Official Reference: FDA – Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
Are You Affected?
EcoMundo already supports several brands with their MoCRA compliance strategy. Contact us to ensure your products meet future FDA safety requirements and to integrate asbestos testing into your risk management systems.
As the U.S. continues to strengthen its regulatory framework under the Modernization of Cosmetics Regulation Act (MoCRA), the FDA has published a proposed rule that could significantly impact cosmetics containing talc.
A New Testing Requirement for Manufacturers
On December 26, 2024, the FDA proposed the introduction of standardized testing methods to detect the presence of asbestos in talc-containing cosmetic products. The proposed rule would require manufacturers to test their products using validated techniques such as:
- PLM (Polarized Light Microscopy)
- TEM/EDS/SAED (Transmission Electron Microscopy / Energy Dispersive Spectroscopy / Selected Area Electron Diffraction)
These methods were reviewed and supported by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) in a peer-reviewed scientific report published in 2022.
Why Is This Change Important?
Asbestos is a known human carcinogen, and while not intentionally added to cosmetics, it can be a natural contaminant in talc, commonly used in powders and makeup products.
Until now, no specific method has been officially required in the U.S. to test for asbestos in cosmetics. This proposal aims to harmonize testing practices and enhance consumer safety.
What Will Be Required If the Rule Is Finalized?
- Batch or representative sample testing of talc-containing cosmetic products.
- Option to rely on a supplier certificate of analysis, subject to verification testing.
- Enforcement provisions: Products failing to comply would be deemed adulterated under the FD&C Act.
- Obligations to retain documentation and demonstrate traceability.
- Products found to contain asbestos would be removed from the market, with potential penalties for non-compliant manufacturers.
A Positive Signal for Responsible Brands
Beyond the critical health concern, this regulation provides clarity and an opportunity for responsible brands to prove their product safety rigor. Fewer recalls, streamlined compliance, and greater consumer trust are all direct benefits.
Comment Period Now Open
👉 The proposed rule is now open for public comment for 90 days via Regulations.gov, referencing docket number FDA-2023-N-4225.
🔍 Official Reference: FDA – Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
Are You Affected?
EcoMundo already supports several brands with their MoCRA compliance strategy. Contact us to ensure your products meet future FDA safety requirements and to integrate asbestos testing into your risk management systems.
