The United States Food and Drug Administration (“FDA”) announced today a proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products” (“Proposed Rule”). This is the first proposed rule that FDA has issued as part of its implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which directed FDA to issue this Proposed Rule, and to issue a final rule not later than 180 days after the date on which the public comment period on the Proposed Rule closes. The Proposed Rule, if finalized, would require manufacturers to test their talc-containing cosmetic products or the talc ingredient used in their products for the presence of asbestos and to keep certain records regarding this testing. Failure to comply with the rule’s testing or recordkeeping obligations would result in FDA deeming a cosmetic product to be adulterated, as would the presence of any levels of asbestos in the product. Comments on the Proposed Rule are due 90 days after its official publication in the Federal Register, which is expected on December 27, 2024, so comments will likely be due on or around March 27, 2025.
Testing Requirements
Scope
The Proposed Rule would apply to all manufacturers of talc-containing cosmetic products. FDA notes that, unlike many other provisions in MoCRA, the rule would also apply to cosmetic products that are subject to the requirements of chapter V of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (i.e., cosmetic products that are also drugs). FDA proposes to define “asbestos” to include “amosite, chrysotile, crocidolite; asbestiform tremolite, actinolite, anthophyllite, winchite, and richterite; and other asbestiform amphibole minerals.”
Test Methods
The Proposed Rule would require manufacturers to employ an analytical approach that includes both PLM (polarized light microscopy) and electron microscopy (TEM/EDS/SAED) to test a representative sample of each batch or lot of a cosmetic product or talc ingredient for asbestos. According to the Agency, both methods are needed because “combining TEM, which enables detection of smaller fibers, with PLM, which enables testing of larger samples, gives the best chance of detecting asbestos.” For both methods, detecting and identifying asbestos would be based on a comparison to reference data in specific ISO standards. If a manufacturer detects any asbestos under the PLM or TEM/EDS/SAED methods, FDA will regard the sample as positive for asbestos.
Talc Suppliers
Alternatively, the Proposed Rule would permit manufacturers to rely on certificates of analysis from the talc supplier rather than conduct the testing themselves. This option would require a manufacturer to verify the reliability of the reported asbestos test results based on testing by the manufacturer or another laboratory upon receipt of the supplier’s initial certificate of analysis and to re-verify annually.
Recordkeeping Requirements
The Proposed Rule would require manufacturers to keep records of asbestos testing. These records would need to include raw data and to describe in detail how samples were tested. If a manufacturer relies on a talc supplier’s certificate of analysis to fulfill its testing obligations, the records must include the certificates as well as documentation showing how the manufacturer verified the reliability of the supplier’s testing. Manufacturers would need to keep such records for three years and make them available to FDA within one business day of the Agency’s request.
Enforcement
The Proposed Rule would establish that failure to comply with the testing and recordkeeping requirements would render the cosmetic product adulterated under section 601(c) of the FDCA. We note that MoCRA did not add a specific adulteration provision to the FDCA relating to talc testing, but FDA is proposing that failure to comply would deem a product adulterated under existing adulteration provisions. Further, because “FDA has determined that asbestos at any level in talc-containing cosmetics may render these products injurious to users,” the Proposed Rule would deem any talc-containing cosmetic that includes any amount of asbestos to be adulterated under section 601(a) of the FDCA.
If you have any questions concerning the material discussed in this client alert, or more broadly about MoCRA implementation, please contact the members of our Food, Drug, and Device practice.
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