Cosmetic Products
Modernization of Cosmetics Regulation Act (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is a law that significantly expands the Food and Drug Administration’s (FDA) authority to regulate cosmetics. It’s the most significant update to the Federal Food, Drug, and Cosmetic Act (FD&C Act) since it was passed in 1938.
Some of the new requirements of MoCRA include:
Mandatory recall authority
The FDA can order a mandatory recall if a cosmetic is adulterated or misbranded.
Facility registration
Cosmetic facilities must register with the FDA by July 1, 2024.
Product listing
Cosmetic companies must list each marketed cosmetic product, including ingredients.
Adverse event reporting
Companies must provide a way for consumers to report adverse effects on packaging.
Safety substantiation records
Companies must develop and maintain safety substantiation records
Good manufacturing practice (GMP) regulations
Companies must follow GMP regulations
Some of the new requirements of MoCRA include:
- Cosmetics Direct: An electronic submission portal for registering and listing cosmetic products and facilities
- Xforms: An SPL authoring tool for registering and listing cosmetic products and facilities
- Form FDA 5066 and Form FDA 5067: Paper forms for registering and listing cosmetic products and facilities