On December 27, 2024, the FDA issued proposed regulations that all cosmetic products containing talc must be tested for the presence of asbestos.
Proposed Regulation
The proposed regulation will, if finalized, be added to the Code of Federal Regulations at 21 CFR 730.3 — Requirements for Talc-Containing Cosmetic Products.
The regulation will apply to all companies that make cosmetic products containing talc.
Testing
As the proposed rule is written, every talc-containing cosmetic product must be tested for the presence of asbestos. There are three options for testing:
- Test a representative sample of every batch or lot of each talc-containing cosmetic product; or
- Test the batch or lot of the talc-containing ingredient before it is used in the cosmetic product; or
- Rely on the supplier’s or manufacturer’s Certificate of Analysis of the talc-containing ingredient. However, if you choose this option, you must annually verify the Certificate of Analysis yourself with in-house or third-party testing.
The specific tests required are included in the regulation.
Records
Accurate and complete records must be kept describing how the samples of product or talc used in your product were tested and the results of the test. Raw data must include detailed information (specified in the regulation).
Records must be kept for three years.
Consequences
A talc-containing cosmetic product is rendered adulterated (and therefore prohibited from being sold) if:
- The talc-constianing product or the talc-containing ingredient in the product is not tested for the presence of asbestos; or
- Asbestos is found to be present in the talc-containing cosmetic product or the talc-containing ingredient used in the product; or
- The required records are not maintained.
From Proposed to Final Regulation
Now that the proposed regulation has been issued, is it open for comments for 90 days (until March 27, 2025). Note that occasionally the comment period is extended.
Once the comment period is closed, the FDA will review the comments and then issue the final regulations. The final may be different from the proposed if the FDA acts on any of the comments received.
MoCRA, which mandated the regulations for testing to detect and identify asbestos in cosmetics, stated that the regulations were to be issued within 180 days of the close of the comment period. That would make the deadline for issuing final regulations September 23, 2025.
However, the proposed regulations were supposed to have been issued by December 29, 2023, so they are already a year late. Since the whole process is well behind schedule, the FDA may issue the final regulations earlier than September 23, 2025.
Effective Date
Today’s notice gives a proposed effective date of 30 days after the publication of the final rule in the Federal Register — making it late October, if not sooner.
However, the effective date could be changed based on the comments received.
If there is pushback on the final regulation, there is a procedure to delay putting it into effect.
In reality, we’ll just have to wait and see what happens in order to know when the final effective date will be.
What To Do Now
There is no doubt that testing will be required for any talc-containing ingredients and/or cosmetic products. The only real question (and it’s not much of a question) is what testing will be required and when it will go into effect.
There is no small business exemption proposed here. If you make any products containing talc, you will need to either make provisions for testing or reformulate with alternate ingredients. Possible alternates to talc include:
- Cornstarch
- Kaolin
- Arrowroot powder
- Rice starch
- Silk powder
- Tapioca starch
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