What is an FDA MoCRA for cosmetics?
MOCRA stands for Modernization of Cosmetics Regulation Act of 2022, a new regulation being implemented by the FDA in 2023 for cosmetic products.
Brief information about MoCRA Registration
Until now, there were no mandatory requirements for cosmetics registration, listing, and adverse event reporting. MoCRA regulation extends FDA’s authority to control cosmetics by enforcing the requirements such as mandatory registration, listing, adverse event reporting, GMP compliance, and mandatory recall requirements.
What are the new MOCRA requirements for cosmetic products?
- Facility registration – The Cosmetic manufacturer, processor, or importer must register with the FDA and renew the registration every two years.
- Cosmetic Product Listing – manufacturer, packer, or distributor of a cosmetic product must list the products marketed by them and annually update the listings.
- Record Access -FDA may access the records related to adverse events and safety substantiation.
- Adverse Event Reporting – The responsible manufacturer, processor, or importer must report serious adverse event reports within 15 days of receiving such reports.
- Updates to labeling requirements
- “For Professional use” labeling if the product is intended for licensed professionals.
- Requirement for domestic contact information for adverse event reporting
- Labeling statement for Allergens and fragrances. FDA to develop regulations to identify Fragrance allergens.
- Testing for the presence of Talc and Asbestos (FDA still to develop the method for testing)
- Good manufacturing practice requirements for manufacturers.
What are the timelines for FDA MoCRA implementation?
FDA may implement requirements such as registration, listing, adverse event reporting, professional use labeling, and mandatory recall requirements at the beginning of the calendar year 2024, and additional requirements may be enforced after FDA develops the regulations.
Registration and listing may be required by the end of December 2023. FDA is still developing a system for product registration and listing.
FDAbasics can help you register, list, prepare safety substantiation and report adverse events. If you have any questions, please contact us.