Modernization of Cosmetics Regulation Act (MoCRA)

Compliance Insight helps cosmetic manufacturers, processors, and brand owners understand their obligations under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). We help businesses identify applicable requirements, assess compliance gaps, and establish practical procedures for ongoing compliance.

• Facility Registration: Owners or operators of facilities subject to registration requirements must register with FDA and renew every two years.
• Cosmetic Product Listing: Responsible persons must submit listings for marketed cosmetic products, including ingredient information, and provide updates annually, unless an exemption applies.
• Safety Substantiation: Responsible persons must ensure adequate substantiation of product safety and maintain supporting records. FDA does not prescribe a single mandatory test for every cosmetic product.
• Serious Adverse Event Reporting: Responsible persons must report serious adverse events associated with cosmetic use in the United States to FDA within 15 business days. Additional reporting obligations apply when qualifying follow-up information is received.
• Exemption Assessment: Certain small businesses qualify for exemptions from facility registration and product listing. These exemptions have limitations and do not remove all MoCRA obligations.

Facility registration and product listing do not constitute FDA approval of a facility or cosmetic product.

Practical MoCRA Compliance Support

Compliance Insight can help your team assess registration and listing obligations, evaluate potential exemptions, organize safety substantiation records, and develop complaint handling and serious adverse event reporting procedures.

Discuss your products, facilities, and compliance priorities with our regulatory consultants to identify your next steps.

How we can help you:

• Regulatory Strategy and Compliance Planning: Developing a customized plan to navigate MoCRA regulations as they are rolled out, tailored to your business needs.
• Labeling and Packaging Review: Ensuring your product labels are fully compliant with MoCRA labeling requirements.
• Adverse Event Reporting Systems: Implementing robust systems for monitoring and reporting adverse events in compliance with MoCRA.
• Registration and Listing: Generating and submitting the facility registration as required and listing the cosmetic products on a timely basis.  Renewing registration and listing biennually.