tags

USA
Cosmetics and Daily Care Products
US FDA Issues Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

On November 26, 2024, the U.S. Food and Drug Administration (FDA) proposes to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This proposed rule, if finalized, would protect consumers by, to the extent it reduces exposure to asbestos, resulting in fewer asbestos-related illnesses.

US FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products

In December 11, 2024, the U.S. Food and Drug Administration (FDA) issued updated guidance for industry on registration and listing of cosmetic product facilities and products. The guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQs (Q20-22) in Appendix B of the guidance are marked as “for comment purposes only”. These three FAQs are available for comments before January 13, 2025.

IARC Reclassified Talc as Probably Carcinogenic to Humans

The International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO), has updated its classification of talc and acrylonitrile, now labeling it as “probably carcinogenic to humans” (Group 2A) for all forms not containing asbestos or asbestiform fibers. This update, published in The Lancet Oncology, may significantly impact the chemical industry, especially under California’s Proposition 65 (Prop 65).

Cosmetics Direct Officially Launched in the United States

FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.