The U.S. Food and Drug Administration (FDA) is announcing the withdrawal of the proposed rule entitled "Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products," which was published in the Federal Register on Dec. 27, 2024.
The FDA is taking this action in response to comments received during the comment period for the proposed rule that warrant further consideration and assessment prior to issuing final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products pursuant to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The decision to withdraw the regulation will be published in the Nov. 28 Federal Register.
FDA Withdraws Proposed Rule for Standardized Asbestos Testing
In the Federal Register of Dec. 27, 2024 (89 FR 105490), the FDA issued the proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products" as part of its implementation of MoCRA.
The proposed rule, if finalized, would have required manufacturers to test their talc-containing cosmetic products or the talc cosmetic ingredient prior to using the talc in manufacturing. Manufacturers would also have to keep records to demonstrate compliance with the rule.
Failure to comply with the rule’s testing or recordkeeping obligations would result in FDA deeming a cosmetic product to be adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act) — as would the presence of any asbestos in a talc-containing cosmetic product, talc used in a cosmetic product or talc intended for use in a cosmetic.
The FDA proposed to define asbestos to include "amosite, chrysotile, crocidolite; asbestiform tremolite, actinolite, anthophyllite, winchite and richterite; and other asbestiform amphibole minerals.” According to the FDA, comments were received requesting consistency with the established definitions or approaches used by other federal agencies to avoid unnecessary confusion.
The Dangers of Asbestos
Asbestos is a deadly human carcinogen for which there is no safe level of exposure. Asbestos contamination has repeatedly been found in talc-based products, raising serious public health concerns. According to the EWG, talc is commonly used in cosmetics to improve texture, absorb moisture or as an inexpensive filler.
The following is a statement from Scott Faber, senior vice president of government affairs for Environmental Working Group (EWG). "Unfortunately, thousands of products that contain talc can be contaminated with asbestos, one of the world’s deadliest substances. Testing for asbestos’s presence is the only way to ensure that products made with talc are safe."
“Inhaling even the tiniest amount of asbestos in talc can cause mesothelioma and other deadly diseases, many years after exposure,” said Tasha Stoiber, Ph.D., senior scientist at EWG. “How much talc is inhaled, and how much is contaminated with asbestos, is difficult to know, but it only takes a single asbestos fiber lodged in the lungs to cause mesothelioma decades later.”
