The Cosmetics Regulation Modernization Act of 2022 (MoCRA) represents the most profound expansion of the FDA’s power over cosmetics since the inception of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This legislation is designed to enhance the safety of daily-used cosmetic products.
Key new authorities granted to the FDA through MoCRA include:
- Facility Registration: Cosmetic manufacturers and processors are required to register their facilities with the FDA every two years. The FDA may suspend a facility’s registration if a product made there poses a serious health risk or could potentially cause death, assuming the problem might affect other products due to systemic issues within the facility. It is unlawful to distribute or sell products from a suspended facility in the U.S.
- Product Listing: A designated responsible person must annually register each cosmetic product being marketed, including a complete list of ingredients. The term “responsible person” refers to the entity—manufacturer, packer, or distributor—listed on the product’s label as mandated by relevant sections of the FD&C Act and the Fair Packaging and Labeling Act.
Exemptions and Decision Tool: The FDA has created a decision-making tool to help determine if registration of a cosmetic facility is necessary. This tool can be accessed online.
Options for Submission:
- Electronic Submissions:
- Cosmetics Direct: This is an FDA tool that facilitates the creation and submission of Structured Product Labeling (SPL) for facility registrations and product listings. It ensures standardized, accurate product information crucial for regulatory compliance and consumer safety.
- Electronic Submissions Gateway (ESG): Alternatively, submissions can be made through the FDA’s ESG or any SPL-compliant software. Registration for an ESG account is recommended well before submission deadlines due to processing times.
- SPL Xforms: This is another method for creating SPL files for facility and product registration.
- Paper Submissions: While electronic submissions are preferred for their efficiency, paper forms are also available for those who need them.
Compliance Deadlines: The FDA will not enforce registration and listing requirements immediately to allow additional time for compliance. Specifically, deadlines have been extended for new facilities and products until mid-2024.
For detailed guidance on these processes, refer to the FDA’s recent publications on the registration and listing compliance policy.
