FDA Issues New Cosmetics Proposed Rule: Let’s Talk About Talc

We have reported extensively on MoCRA since its enactment on December 29, 2022, and are fairly certain that everyone is bored to tears of yet more information on registration and listing requirements (please see here, here, here, and here for more on that point). Never fear — the FDA has now provided us a proposed rule on one of the less oft-discussed MoCRA sections: requirements regarding talc-containing cosmetics.

Among its many other provisions, MoCRA required the FDA to promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. On December 26, the FDA announced the publication of the proposed rule addressing these new regulations.

Many of us are familiar with talc (mined as naturally occurring hydrous magnesium silicate) as used in combination with other ingredients to make baby powder. For cosmetic products, talc may be used in a variety of different ways, for example, to help control shine, assist with moisture and oil absorption, and prevent caking. Because — and per the FDA — asbestos (a known human carcinogen) is found in the same rock types that host talc deposits, it may be inseparable from talc during the mining process. As such, talc-containing cosmetics may inadvertently contain asbestos fibers. As such, the new proposed rule aims to protect users of talc-containing cosmetics from potential exposure to asbestos.

In short, the proposed rule contains provisions regarding testing, record keeping, and enforcement of the new regulations (note that the proposed rule additionally contains numerous proposed definitions, including for terms such as “representative sample” and “asbestos”).

Testing Requirements

• Per the proposed rule, the FDA proposes that the requirements for testing apply to all manufacturers of talc-containing cosmetics. Additionally, the FDA notes that cosmetics that are also regulated as drugs will also be subject to these new regulations regarding talc.
• The FDA proposes to require manufacturers of talc-containing cosmetics to test for asbestos contamination using Polarized Light Microscopy (with dispersion staining) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction.
• To provide manufacturers with greater flexibility, the FDA proposes to allow manufacturers to either (1) test the talc themselves or (2) rely on a certificate of analysis from the talc supplier, prior to using the talc in the manufacturing of a talc-containing cosmetic. However, note that, under the proposed rule, if a manufacturer chooses to rely on a talc certificate of analysis, they must qualify the supplier by establishing and maintaining the reliability of the supplier’s certificate of analysis through verification of the results of the supplier’s tests for asbestos.
• The FDA proposes that, at a minimum, manufacturers test a representative sample of each batch or lot of each talc-containing cosmetic or talc ingredient for asbestos.

Record Keeping Requirements

• Under the proposed rule, manufacturers would be required to keep records of testing for asbestos that show test data, including raw data, and to describe in detail how samples were tested.
• For manufacturers relying on a certificate of analysis for the talc supplier, the proposed rule states that records must include any certificate of analysis received from the supplier for testing of the talc used to make the finished product, and documentation of how the manufacturer qualified the supplier by establishing and maintaining the reliability of the supplier’s certificate of analysis through verification of the results of the supplier’s tests for asbestos.
• The proposed rule would require that records be made available within one business day, upon request, to an authorized FDA representative for inspection and copying. The proposed rule would additionally require that such records be retained for a period of three years after the date such record was created.

Enforcement

• Under the proposed rule, the following would render a cosmetic and/or the talc used or intended for use in such a cosmetic adulterated under the federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 361 [FDCA § 601] (adulterated cosmetics)):
  • The failure to test for asbestos in a talc-containing cosmetic.
  • The failure to maintain testing records as required for a talc-containing cosmetic.
  • The presence of asbestos in a talc-containing cosmetic.
  • The presence of asbestos in talc intended for use or used in a cosmetic.

Comments should be submitted by March 27, 2025, to ensure that the FDA considers them before the agency begins work on the final rule. Importantly, note that the FDA is proposing that the final rule become effective 30 days after its date of publication.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA, would like guidance on complying with these new requirements, or would like assistance preparing a comment on the proposed rule, please contact ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group.