The US Food and Drug Administration (FDA) has launched Cosmetics Direct, an electronic submission portal for registration and listing of cosmetic product facilities and products as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Cosmetics Direct is dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions to FDA.
FDA is also developing paper forms for cosmetic product registration and cosmetic product listing as an alternative submission tool that are anticipated to be available soon.
FDA has meanwhile issued final industry guidance on cosmetic product facility registrations and product listings under MoCRA.
The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions to the registration and listing requirements.
In addition, FDA said it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the 29 December statutory deadline, or until 1 July 2024, to provide regulated industry additional time to comply with these requirements.
FDA also said it does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after 29 December 2022, or the listing requirement for cosmetic products first marketed after 29 December 2022 until 1 July 2024.
