MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It expands the FDA’s authority over cosmetics, introduces mandatory registration, safety, and reporting requirements, and aims to strengthen public health protections for cosmetic products.
Key aspects of MoCRA include:
- Facility Registration: Cosmetic manufacturers and processors must register their facilities with the FDA and update such registration biennially.
- Product Listing: A responsible person must list every marketed product (including ingredients) and renew such listing annually.
- Good Manufacturing Practices (GMP): The law requires compliance to GMPs, which sets standards for product safety and quality in manufacturing.
- Adverse event reporting: Manufacturers must track and report any serious adverse health incidents linked to their products.
- Safety substantiation: Companies must do all safety testing and keep evidence.
- Labeling requirements: Product labels must be FDA compliant.
Certain Small businesses may be exempt from some MoCRA requirements, although exemptions do not apply to products intended for use in the eyes, injected, or otherwise specifically regulated under FDA drug regulation.
Liberty Management Group Ltd can help facilities with FDA Registration & product listing and label compliance.
Namrata
Regulatory Consultant