New FDA Rule Targets Asbestos Risks in Talc-Based Cosmetics

In a significant move to enhance consumer safety, the U.S. Food and Drug Administration (FDA) has proposed a new rule aimed at standardizing how manufacturers test for asbestos in talc-containing cosmetic products. This rule—titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products”—marks a crucial step forward in regulatory oversight, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Why This Matters

Asbestos is a known human carcinogen, and its presence—even in trace amounts—in personal care items poses a serious health risk. Talc, a common ingredient in products like baby powder, foundation, and body powders, can be contaminated with asbestos due to their geological proximity. Despite this known risk, the FDA has never before required a specific method for asbestos testing in cosmetic products—until now.

What the Proposed Rule Would Require

If finalized, the rule would mandate that manufacturers of talc-containing cosmetic products test their products for asbestos using two advanced scientific methods:

  • Polarized Light Microscopy (PLM)
  • Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED)

These testing standards are in line with expert recommendations from the Interagency Working Group on Asbestos in Consumer Products (IWGACP), which has worked with the FDA since 2018 to develop science-based guidance on asbestos detection.

Manufacturers would need to:

  • Conduct testing on representative samples of each batch or lot of the finished product or the talc ingredient.
  • Verify reliability if relying on supplier-issued certificates of analysis.
  • Maintain thorough records to demonstrate compliance.

Adulteration & Enforcement Provisions

The rule also includes critical enforcement mechanisms. Under the Federal Food, Drug, and Cosmetic Act:

  • Products found with asbestos, or those made with contaminated talc, would be deemed adulterated under sections 601(a) and 601(c).
  • Failure to follow required testing and recordkeeping protocols would also lead to a finding of adulteration.

This means that any talc-based cosmetic product not in compliance could be subject to regulatory action, including product recalls and market removal.

Potential Benefits

Beyond protecting public health by reducing exposure to a dangerous carcinogen, the proposed rule offers practical benefits for manufacturers. By adhering to uniform testing standards, companies may experience fewer product recalls, improved supplier oversight, and greater consumer trust.

For more details and updates on this proposed rule, visit the FDA’s official announcement page.

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