THE WHAT? The US Food & Drugs Administration (FDA) has issued final guidance for the industry on the requirement for cosmetic product facility registrations and product listings ushered in under the Modernization of Cosmetics Regulation Act, 2022 (MoCRA).

THE DETAILS The regulatory body has also unveiled an electronic registration and listing submission portal. Cosmetics Direct, as the portal has been dubbed, is now available for manufacturers to use. Paper forms as an alternative submission tool are in development.

THE WHY? 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.