The U.S. Food and Drug Administration (FDA) has launched Cosmetics Direct on 18 December! Cosmetics Direct is an electronic portal for registering and listing cosmetic product facilities and products. This initiative, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), aims to streamline the submission process for the industry. Cosmetics Direct provides a user-friendly interface for facility registration and product listing, making submissions more efficient.
The FDA’s final guidance assists stakeholders in the cosmetic industry with registration and listing submissions. It outlines who is responsible for these submissions, the information required, the submission process, and the timelines. An essential requirement is obtaining an FDA Establishment Identifier (FEI) number before submitting facility registrations. The guidance also explains certain exemptions for small businesses. However, these do not extend to facilities or responsible persons for products with specific use cases, such as eye contact products or injectables.
Furthermore, the FDA has delayed the enforcement of these requirements until July 1, 2024, providing additional time for the industry to comply. This delay applies to cosmetic product facility registration and product listing requirements under MoCRA. The delay also extends to facilities that began manufacturing or processing cosmetic products after December 29, 2022, and for products first marketed after this date.
These developments by the FDA represent a significant improvement in the regulatory process for cosmetic products. They enhance efficiency and ensure better compliance with the regulatory framework. Businesses in the cosmetics industry must stay informed about these changes and adhere to the new processes to ensure smooth operations and regulatory compliance.