THE WHAT? The US Food and Drug Administration (FDA) has issued final guidance clarifying its authority to order mandatory cosmetics recalls under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), strengthening regulatory oversight of cosmetic product safety.
THE DETAILS Published on 22 October 2026, the guidance, titled Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry, outlines the circumstances under which the FDA may order a mandatory recall, the procedures involved and expectations for industry compliance. The document implements provisions under Section 611 of the Federal Food, Drug, and Cosmetic Act, introduced through MoCRA. Following a public consultation on the draft guidance issued in December 2025, the FDA finalised the document without substantive changes. The agency continues to encourage companies to initiate voluntary recalls when cosmetics fail to meet regulatory requirements.
THE WHY? The guidance provides cosmetics manufacturers, brands and distributors with greater clarity on their obligations when products present safety concerns, reinforcing the FDA’s expanded enforcement powers under MoCRA. The framework also highlights the importance of product safety monitoring, traceability and established recall procedures across the US cosmetics supply chain.
Source: FDA
