Modernization of Cosmetic Regulation Act of 2022 (MoCRA)
On December 29th, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
MoCRA added Section 607 to the Federal Food, Drug, and Cosmetic Act (FD&CA) to establish requirements for cosmetic product facility registration and product listing. It enhances the FDA's authority, establishes a uniform national framework, and promotes safety and innovation.
Do I have to list my cosmetic products under MoCRA?
We get it, being a small business is hard when it comes to compliance. We have created a short survey to help you navigate if you need to list your cosmetic products or if you do not. A real person (yes, a REAL person!) will review your answers and provide you with a general recommendation based upon your responses within 24 hours to let you know if you need to list your products or not with the FDA.
MoCRA grants FDA expanded authority to regulate cosmetics. However, small businesses have been uncertain about their obligations under the regulation, particularly regarding the "small business exemption."
Read our article at the link below to learn if you qualify under the small business exemption.
Small Business Exemption
Important Compliance Dates
As of December 29, 2023, the following items are currently in effect:
Adverse Event Recordkeeping and Serious Adverse Event Reporting
Adequate Substantiation of Safety and Recordkeeping of Safety Substantiation
Responsible Person has a domestic address or phone number, or electronic contact information so they can receive adverse event reports
Professional Use Labeling requirements
FDA’s new enforcement:
Mandatory Recall Authority
Facility Suspension
Preemption
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
In addition, FDA does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
MoCRA and the Responsible Person Concept
Are you aware of the differences between the EU and US Responsible Person under the Modernization of Cosmetics Regulation Act (MoCRA)? Our latest article outlines the obligations and responsibilities of the US Responsible Person, including adverse event reporting and product listings, as well as the introduction of the US Agent. Confiance Cosmetic Group is here to assist with meeting MoCRA requirements. Stay informed and compliant with MoCRA regulations.
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