A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. The passing of the law which, among other things, amended the Federal Food, Drug, and Cosmetic Act to include requirements for facility registration and product listing, safety substantiation, adverse event reporting, and requirements for FDA to issue several new regulations, brought excitement and anxiety. Excitement that after about a decade the FDC Act finally was amended giving cosmetics more legitimacy; anxiety because MoCRA seemed a substantial change for many involved in the business of cosmetics. There remains much uncertainty about the practical aspects of the new requirements.
As we previously reported, MoCRA includes various provisions requiring that FDA develop regulations within a specific time frame. A brief review of FDA actions (or lack thereof) in 2024 shows that FDA failed to meet any of the statutory deadlines set by MoCRA. FDA's report card therefore shows a big Incomplete.
MoCRA includes several self-executing requirements, such as registration and product listing, adverse event reporting requirements and labeling for adverse event reporting. However, MoCRA also requires action by FDA. Notably, the law requires that FDA develop three major rules within specific time frames. MoCRA mandates that FDA develop a regulation regarding the testing for asbestos in talc (statutory deadline for proposed rule Dec. 29, 2023), a regulation for fragrance allergen labeling (statutory deadline for proposed rule June 29, 2024); and good manufacturing practice regulations (statutory deadline for proposed rule Dec. 2024). FDA has failed to meet all deadlines for these three MoCRA rules.
Just on the cusp of 2024, on Dec. 27, 2024, almost a year after the statutory deadline, FDA published a proposed rule for asbestos testing of talc.
The proposed rule on asbestos testing describes the test methods that, if finalized, manufacturers of talc-containing cosmetic products must use to detect and identify asbestos in these products. FDA proposes to require that manufacturers test a representative sample of each batch or lot of a talc-containing cosmetic product or of each batch or lot of the talc ingredient to be incorporated in the 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). Alternatively, manufacturers may rely on a certificate of analysis for each batch or lot from a qualified talc supplier prior to using the talc in a talc-containing cosmetic. Not surprisingly, reliance on a supplier is acceptable only if the supplier used both PLM and TEM/EDS/SAED to test the talc.
FDA recognizes that the proposed testing method is different from what most of the industry has used thus far. According to FDA, the requirement for the use of both PLM and TEM/EDS/SAED is consistent with established scientific opinions recognizing the limitations of PLM which may result in false negative test results. FDA added the requirement to use TEM/EDS/SAED to ensure sensitivity and specificity. According to FDA, “combining TEM, which enables detection of smaller fibers, with PLM, which enables testing of larger samples, gives the best chance of detecting asbestos.”
FDA proposes to require that manufacturers keep records of testing for asbestos that show test data, including raw data (including microscopy images, spectra, diffraction patterns and bench sheets), and describe, in detail, how samples were tested. If the manufacturer chooses to rely on a certificate of analysis from the talc supplier, the records must include any certificate of analysis from the supplier for testing of the talc used to make the finished product, and documentation of how the manufacturer qualified the supplier. Records written in English (or when requested an English translation) must be made available for inspection and copying to an authorized FDA representative within one business day, upon request. FDA proposes to require that records must be retained for a period of 3 years after the date such records were created.
Presence of asbestos at any level in a cosmetic product, or in talc used in a cosmetic product, causes that cosmetic product or talc to be adulterated under the FDC Act. In addition, failure to operate in compliance with the testing or recordkeeping requirements would cause the talc containing cosmetic products to be adulterated under the FDC Act.
Comments to the proposed rule must be submitted by March 27, 2025
Target dates for the two other rules that FDA must issue pursuant to MoCRA, have been pushed to January 2025 for the proposed rule for fragrance allergen labeling and to October 2025 for the proposed rulemaking for good manufacturing practices. If FDA meets those deadlines, 2025 will be a busy year for both FDA and industry. Hopefully, FDA will also find time to develop guidance for industry answering the many questions that remain about MOCRA's requirements for adverse event reporting and related labeling requirements, as well as MOCRA's safety substantiation standard for cosmetics.
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