FDA Reverses Proposed Rule for Asbestos Testing in Cosmetics
In a surprising regulatory reversal, the U.S. Food and Drug Administration has withdrawn its December 2024 proposed rule requiring standardized asbestos testing in talc-containing cosmetic products. This decision has been made in light of technical and legal complexities raised during the public comment period.
The now-withdrawn rule would have mandated manufacturers to test talc-containing cosmetics using both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) methods. The aim was to detect any asbestos contamination. Any detected asbestos, regardless of the level, would have rendered products automatically adulterated under federal law.
“We are withdrawing the proposed rule to reconsider the best means of addressing the issues,” stated the FDA. The agency received 49 comments questioning everything from testing definitions to statutory authority. It’s worth noting that independent investigations have periodically found asbestos in cosmetic products, particularly those marketed to children and teens.
The withdrawal of this rule affects the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). However, the FDA confirmed it will issue a revised proposed rule. Talc, known for its moisture-absorbing properties, is widely used in cosmetics including mascaras, eye shadows, foundations, and nail polish.
Source: Newsweek