On 8 November 2023, the US Food & Drugs Administration (FDA) announced that it had extended by six months the deadline, initially set for 29 December 2023, for the registration of facilities and product listings under the Modernization of Cosmetics Regulation Act (MoCRA). This announcement was made at the same time as the publication of a guidance designed to help companies comply with these requirements.
“This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing,” the FDA says. “It discusses FDA’s compliance policy for these requirements.”
At the same time, the FDA announces to delay enforcement of these requirements for six months to help ensure that industry has sufficient time to submit facility registration and product listing information, i.e. until 1 July 2024. It also specifies that its guidance documents do not establish legally enforceable responsibilities, but describe the Agency’s current thinking on a topic and should be viewed only as recommendations.
The guidance Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing is available free of charge on the FDA website.
Source
• Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing, FDA, 8 November 2023
