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FDA Proposes Mandatory Asbestos Testing for Talc-Based Cosmetics: What It Means for Industry Compliance
Overview
On March 25, 2025, the U.S. Food and Drug Administration (FDA) proposed a long-anticipated rule requiring mandatory, standardized testing for asbestos in talc-based cosmetic products. This move is a direct response to consumer safety concerns and past reports of asbestos contamination in cosmetic powders.
The proposed rule is open for public comment and signals a shift toward tighter oversight under the Modernization of Cosmetics Regulation Act (MoCRA).
What the FDA Is Proposing
The FDA’s proposal would require:
- All cosmetic products containing talc to be tested for asbestos contamination
- Testing to be conducted using a specific, validated method: the polarized light microscopy (PLM) and transmission electron microscopy (TEM) protocol
- Documentation of testing to be maintained and available for FDA inspection
Why This Matters
For years, advocacy groups and lawsuits have pressured regulators to address the risks associated with talc. Asbestos, a known carcinogen, can contaminate talc during mining if not properly purified. Although many brands claim their products are asbestos-free, until now, no standard testing method was required by law.
Impact on Manufacturers and Importers
- Foreign manufacturers must comply if their products are marketed in the U.S.
- A U.S. Agent or Cosmetic Responsible Person will be expected to maintain documentation and respond to FDA inquiries.
- Non-compliance could result in detentions, recalls, or market bans under MoCRA.
What You Should Do Now
- Review your product portfolio: do any formulations contain talc?
- Prepare to implement validated testing methods
- Update your FDA MoCRA compliance checklist — this proposal is likely to move quickly into final rule stage
Cosmereg Can Help
If you manufacture or distribute talc-based cosmetics, Cosmereg can assist you with:
- MoCRA-compliant documentation
- Cosmetic U.S. Agent representation
- Testing protocols and supplier verification
📩 Contact us to review your talc-based product line for regulatory risks.
