Sungo

On December 16, 2023, the US FDA officially opened the US FDA Cosmetic application system -FDA Cosmetic Direct, which means that all enterprises that have sold or plan to sell cosmetics in the United States must complete the REGISTRATION OF COSMETIC PRODUCT FACILITY and COSMETIC PRODUCT LISTING within the specified period.

On December 29, 2022, the United States passed the Modernization of Cosmetics Regulation Act of 2022 (MOCRA). After MOCRA goes into effect, all companies selling cosmetics in the US will be mandated to register their facilities and submit product listings to FDA. The Voluntary Cosmetic Registration Program (VCRP) is now history.

On August 7, 2023, according to the requirements of MOCRA, the US FDA issued a draft guidance for cosmetic facility registration and product listing for public comment. The draft guidance provides advice and instructions for involved people and is intended to assist them in submitting cosmetic facility registrations and product listing to the FDA. In addition, FDA is developing an electronic submission system for cosmetic registration to simplify the registration of cosmetic product facility and cosmetic product listing.

On November 8, 2023, the FDA issued a guidance and delayed the opening of the electronic system and the mandatory registration of cosmetic facility and product listing. The FDA has decided to postpone the mandatory implementation date for facility registration and product listing to 1 July 2024, taking into account that cosmetic companies may need more time to collect the relevant information required for registration and listing.

Before cosmetics facility registration, the enterprise must appoint a US agent to assist with the application and deal with the communication matters with FDA. In addition, the company must ensure that it has an FEI (FDA Establishment Identifier) number.

Although the registration deadline has been extended to July 1, 2024, in order to successfully complete the registration, SUNGO suggests that cosmetics manufacturers and distributors should be prepared in advance to meet the transition requirements more steadily.

Moreover, to reduce the burden on the system, FDA encourages early completion of electronic submissions of registrations and listings to ensure a more efficient and smoother review process before the deadline.