USA – ZOOP | Global Cosmetic Regulatory Expert

FDA Launches Unified Adverse Event Monitoring System (AEMS)

On March 11, 2026, the U.S. Food and Drug Administration (FDA) officially announced the launch of the Adverse Event Monitoring System (AEMS). This brand-new unified platform and interactive public data dashboard is designed to analyze and process adverse event reports with greater efficiency. The system is scheduled to be fully operational by the end of May 2026. This transition will bring significant changes to the industry landscape and the way the public accesses data. Here is the core information you need to know: A “Unified” Era: Covering All Regulated Products The launch of AEMS marks a major milestone in the FDA’s data integration efforts. It will provide real-time adverse event reporting across all FDA-regulated product categories, including: Retiring Legacy Systems To achieve this integration, the FDA will decommission several aging, decentralized reporting systems across various centers. The new AEMS will directly replace the following well-known platforms: By consolidating these systems […]

USA

FDA Issues Reports on PFAS and Records Access: Official Draft Guidance Must Be Reviewed!

Entering 2026, the regulatory hammer of the U.S. Food and Drug Administration (FDA) has fallen in rapid succession. Within just three weeks, the FDA released two critical documents targeting PFAS (“forever chemicals”) and records access authority. The release of these documents is no coincidence; they are direct products of the comprehensive implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For companies exporting to the U.S., the threshold for compliance has been raised once again. I. PFAS Investigation Report: 51 Ingredients Named, Data Gaps Remain a Challenge On December 29, 2025, the FDA submitted its highly anticipated report on PFAS in cosmetics to Congress. This authoritative conclusion was derived from the first wave of product listing data under MoCRA. Core Findings: II. Records Access Guidance: What’s in the FDA’s “Inspection Kit”? On January 21, 2026, the FDA issued draft industry guidance regarding records access authority under Sections 605

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