On November 8, 2023, the US FDA released the "Industry Guide: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing" (FDA-2023-D-1716), and announced the requirement to delay the implementation of cosmetic factory registration and product listing by 6 months, Enterprises only need to complete cosmetic factory registration and product listing before July 1, 2024, and will not enforce the requirements for factory registration and product listing in MoCRA before July 1, 2024, to ensure that relevant enterprises have sufficient time to prepare and submit relevant information.

The FDA will prepare to receive factory registration and product listing information by December 29, 2023, and encourage capable companies to complete submissions before the original deadline.

Background

On December 29, 2022, US President Biden signed the Comprehensive Appropriations Act of 2023 (H.R. 2617), which included an independent bill, the Modernization of Cosmetics Regulations Act of 2022 (MoCRA), amending Chapter VI of the Federal Food, Drug, and Cosmetic Act.

MoCRA has provided new authorizations to the FDA, including:

Facility Registration:

Cosmetic manufacturers and processors must register their facilities with the FDA, update their content within 60 days of any changes, and update their registration every two years.

Product Listing:

The responsible person must list each cosmetic product listed to the FDA, including its ingredients, and provide any updates annually.

Responsible person: refers to a cosmetic manufacturer, packager, or distributor whose name appears on a cosmetic label under Section 609 (a) of the FD&C Act or Section 4 (a) of the Fair Packaging and Labeling Act.

Reference link

https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing