Mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the U.S. Food and Drug Administration (FDA) announced a proposed rule—yet to be finalized—to establish standardized testing methodologies to detect the presence of asbestos fibers within talc used in cosmetic products.
The FDA determined that the current non-regulatory methods for testing cosmetic talc for the presence of asbestos were inadequate because they lacked unambiguous, standardized guidelines for analytical laboratories to consistently adhere to without modification. Even utilizing the most sensitive methodologies, laboratories testing the same products have reached differing conclusions about the presence of asbestos. Due to the lack of clear regulations, many analytical laboratories have modified existing asbestos testing methods—designed for air and building materials in schools and workplaces—in an attempt to test for asbestos in talc-containing cosmetics.
According to Linda Katz, director of the FDA’s Office of Cosmetics and Colors, the agency has “carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products.” According to the FDA, the proposed rule would require manufacturers of talc-containing cosmetic products to test for the presence or absence of asbestos using an analytical approach that includes both Polarized Light Microscopy (“PLM”) (with dispersion staining) and Transmission Electron Microscopy (“TEM”)/Energy Dispersive Spectroscopy (“EDS”)/Selected Area Electron Diffraction (“SAED”) to detect and identify the presence of asbestos. Manufacturers may alternatively rely on a certificate of analysis from the talc supplier. The proposed rule contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule.
A failure to comply with the requirements would render the talc-containing product “adulterated” under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), meaning “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
Regarding the microscopy protocols, the FDA’s proposed rule references International Organization for Standardization (“ISO”) standards for both the qualitative and quantitative determination of asbestos as well as an ISO standard for the quantitative analysis air samples.
Over the past decade, the results of the FDA’s own testing of talc-containing cosmetic powder products revealed a shift. While the agency’s 2010 analysis of 34 talc-containing cosmetic powder products of various types found no asbestos contamination, its 2019 follow-up study detected asbestos contamination in nine out of 52 talc-containing cosmetic powder products tested. Yet, both studies employed the same microscopy approaches proposed here, highlighting the need for a regulatory testing standard.
With this proposed rule, the FDA has enshrined that, “asbestos at any level in talc-containing cosmetic products may render these products injurious to users.” The FDA proposes adopting a broad mineralogical definition of asbestos in talc-containing cosmetic products to “include all hazardous asbestiform amphibole minerals that might be detected and identified using the proposed testing methods,” which includes the six commercial minerals: amosite, chrysotile, crocidolite, asbestiform tremolite, actinolite, and anthophyllite, in addition to as of yet to be regulated minerals: winchite and richterite. Though the proposed rule enumerates these eight minerals that, if detected, would render the talc-containing cosmetic powder product adulterated, the proposed rule goes further to include a catchall, “and other amphibole minerals in the asbestiform habit,” within the proposed definition of asbestos.
Having tested hundreds of samples, the FDA has recognized the TEM/EDS/SAED method’s sensitivity may detect one asbestos fiber per 0.1 microgram of talc and that such a detection corresponds to an estimated 107 fibers per gram of a talc-containing cosmetic product, representing approximately 10−5 percent of asbestos by weight. Therefore, the FDA proposes that the detection of a single asbestos fiber in a sample is the appropriate basis for determining whether the talc is adulterated.
This long-awaited proposal by the FDA represents a significant shift in talc-containing cosmetic product regulation, establishing for the first time standardized testing protocols for detecting asbestos in talc-containing cosmetics. By mandating specific testing methodologies, adopting a broader definition of asbestos that includes previously unregulated minerals, and setting an extremely stringent contamination threshold—even a single fiber constitutes adulteration—the FDA is fundamentally reshaping how the cosmetics industry must approach talc safety. The proposed rule not only addresses historical inconsistencies in testing procedures but also reflects the agency’s position that there is no safe level of asbestos exposure in cosmetic products, marking a new era in consumer protection standards.
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