Key Takeaways

• What Happened: The Food and Drug Administration proposed a rule to require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods.
• Who’s Impacted: Manufacturers of talc-containing cosmetic products.
• What Should You Do: Consider submitting comments on this proposed rule by March 27, 2025.

Mandatory testing of talc-containing cosmetic products is coming. At the end of December, the Food and Drug Administration (FDA) proposed a cosmetics rule and test method for asbestos in talc that was required under Section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 89 Fed. Reg. 105492 (Dec. 27, 2024). MoCRA added substantial new cosmetics provisions to the Federal Food, Drug, and Cosmetic Act (FFDCA), including a requirement for the FDA to establish and require the use of standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. For more details on MoCRA, see here.

Talc is mined as naturally occurring hydrous magnesium silicate and is used in many cosmetic products to absorb moisture, prevent caking, render makeup opaque, or improve product texture. However, the rock types that host talc deposits often also contain asbestos, which is a known carcinogen when inhaled. As noted in the Environmental Protection Agency’s latest risk evaluation for asbestos (November 2024), “If vermiculite or talc are mined from ore that also contains asbestos fibers, it is possible that the resulting vermiculite or talc minerals are contaminated with asbestos fibers.” (EPA’s risk evaluation did not consider asbestos in talc for use in cosmetics.) FDA has repeatedly monitored for asbestos in talc-containing cosmetic products, and though it found none in the products sampled in 2010 and 2023, the agency detected asbestos in 9 of 52 products it tested in 2019.

As laboratories lacked standardized testing methods that can be followed without modification to test for asbestos in talc-containing cosmetic products, MoCRA required that FDA develop such methods. This proposed rule aims to standardize testing in the industry so that the public can rely on talc-containing cosmetic products without concerns of asbestos contamination. This standardization would apply to all manufacturers of talc-containing cosmetic products, including cosmetic products that are subject to the requirements of Chapter V of the FFDCA, such as cosmetic products that are also drugs.

Proposed Testing Requirements

The proposed rule would require manufacturers to test a representative sample of each batch or lot of a talc-containing cosmetic product for asbestos using both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED). FDA proposes defining “representative sample” as “a sample that consists of a number of units drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.” This definition is intended to provide flexibility and to align with the definition of “representative sample” in other FDA-covered product areas.

Under the proposed rule, a sample would be deemed to contain asbestos if asbestos is detected at or above the applicable detection limit using either method. FDA has specifically requested comment on this issue.

Additionally, the proposed rule would require manufacturers to either test each batch or lot of the talc cosmetic ingredient or rely on a certificate of analysis for each batch or lot from a qualified talc supplier. If a manufacturer chooses to rely on a talc certificate of analysis, the manufacturer must annually qualify the supplier by verifying the reported asbestos test results based on their own testing or that of a third-party laboratory to establish the certificate’s reliability.

Recordkeeping

The proposed rule would require manufacturers to keep certain records to demonstrate compliance. Manufacturers would need to keep records of testing for asbestos that show test data, including raw data, and to describe in detail how samples were tested. If a manufacturer relies on a certificate of analysis from its talc supplier, 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 as described above.

The proposed rule would also require that these records be made available to the FDA within one business day of a request from the agency. The records would need to either be in English or have an English translation available and would need to be retained for three years after the date that the record was created. FDA is specifically soliciting comment on the timeframe for retention. The agency wants to ensure the timeframe is sufficient given the timing from testing to when the product containing the tested talc makes it to consumers and the average length of time consumers keep or use the product.

Enforcement

FDA proposes to enforce the new rule’s requirements under the FFDCA’s prohibition on the sale or distribution of adulterated cosmetics products, 21 U.S.C. § 331(a). As there is no established safe level below which asbestos could not cause adverse health effects, FDA will consider asbestos at any level in talc-containing cosmetic products to be injurious to users. Therefore, the proposed rule would codify in regulations that if asbestos is present in a talc-containing cosmetic product, or if a manufacturer fails to test its talc-containing cosmetic or its talc ingredient for asbestos or to maintain records or such testing, that cosmetic is adulterated under the FFDCA and illegal to sell or distribute.

FDA proposes that this rule become effective 30 days after the date of publication of the final rule in the Federal Register. For those interested in commenting on the proposed rule, parties must should submit comments to the docket by March 27, 2025.

As noted, MoCRA requires FDA to publish a final rule on testing talc-containing cosmetic products. With a new administration soon to take office, it is unclear whether the Trump FDA will proceed to final rulemaking once the comment period ends or take other action.