FDA cosmetic facility registration, also known as MoCRA Registration, is a new FDA requirement that cosmetic product manufacturers and processors must register their facilities with the U.S. Food and Drug Administration (FDA). This requirement is part of the Modernization of Cosmetics Regulation Act (MoCRA), passed in 2022 and the most significant expansion of the FDA’s authority to regulate cosmetics since 1938.
Who requires MoCRA Registration?
MoCRA Registration is required for all facilities that manufacture or process cosmetic products for distribution in the United States, with a few exceptions. For example, small businesses with annual gross receipts of less than $1 million are exempt from registration.
When to register with the FDA?
The deadline to register facilities under MoCRA is July 1, 2024.
Why is MoCRA Registration important?
MoCRA Registration is important because it will help the FDA better understand the cosmetics industry and identify potential safety risks. The FDA will use the information collected through MoCRA Registration to conduct inspections, investigate complaints, and take enforcement action if necessary.
How much is the fee for MoCRA Registration?
There is no FDA fee for MoCRA Registration. Please visit the fee page for the LMG fee for preparing and submitting SPL and US Agent service for foreign facilities.
Is there an annual renewal requirement?
Cosmetic facilities must renew their registration every two years.
Why is MoCRA facility renewal important?
MoCRA facility renewal is important because it helps the FDA ensure that cosmetic facilities are still in compliance with the law and producing safe products.