The U.S. Food and Drug Administration is moving from legislative transition to operational oversight under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), representing the most significant expansion of federal cosmetics authority in decades. The agency is actively reviewing facility registrations, product listings, and safety substantiation records, while signalling increased attention to high-profile ingredient categories such as PFAS, formaldehyde releasers, and other substances of emerging toxicological concern. Importantly, MoCRA does not introduce a formal pre-market approval system for cosmetic products—nor does the EU operate such a system—but it significantly strengthens pre-market compliance obligations and post-market enforcement tools. Manufacturers must now maintain documented safety substantiation, comply with mandatory registration and listing requirements, report serious adverse events, and operate under forthcoming GMP standards, while the FDA has gained authority to mandate recalls and suspend facility registrations in cases of non-compliance. At the same time, expanding state-level measures—particularly targeting PFAS and contaminants such as 1,4-dioxane—are adding further regulatory complexity beyond the federal framework. For industry, MoCRA marks a transition from a historically limited oversight model toward a structured, documentation-driven compliance regime with tangible enforcement consequences. Strategically, U.S. cosmetics regulation is entering a more assertive and systematised phase, reducing the historical regulatory gap with the EU.