Modernization of Cosmetics Regulation Act (MoCRA) Readiness

Kevin Linde

Course description

The FDA has expanded their authority with the Modernization of Cosmetics Regulations Act (MoCRA) to regulate the cosmetics industry. This regulation requires cosmetic product manufacturers to adhere to specific requirements at key deadlines to ensure the safety of cosmetics products that are used by consumers daily.

This accredited training course will provide participants with an overview of MoCRA, focusing on the scope, regulation expectations, and deadlines set forth by the FDA. The course aims to address each of the various requirements discussed in the act, including facility registration, submission of product listing, new label requirements, monitoring of serious adverse events, GMP compliance, and safety substantiation testing.

The course objectives include delving into each of these requirements to understand scope, actions needed, and timeline constraints associated with compliance to the act. Additionally, participants will have knowledge on consequences of not adhering to requirements. By the end of the course, attendees will understand what their company needs to do to comply with this act in 2024 and plan for 2025.

Live attendees will have the option to directly ask questions to the instructor.

Upon completion of this course, you will be able to:

• Identify and explain the importance of the Modernization of Cosmetics Regulations Act (MoCRA) of 2022
• Demonstrate understanding of MoCRA, including the areas of the industry in scope and the detailed requirements associated with each phase set forth by the FDA.
• Develop and plan your 2025 initiatives to ensure compliance.
• Apply the FDA decision tree tool for MoCRA for various scenarios.
• Navigate Cosmetics Direct for product listing
• Outline the consequences that may apply if the MoCRA compliance requirements are not met

COURSE OUTLINE

Overview of Modernization of Cosmetics Regulations Act (MoCRA) of 2022

• Background on MoCRA
• Overview MoCRA Contents
• Consequences for failure to comply

2024 Requirements

• MoCRA – Who does this apply to?
  o MoCRA scope
  o Exemptions
• Requirements
  o Facility Registration
  o Product Listing
  o FDA Recall
  o Label Updates
• Deadlines
  o Phase 1 Requirement Deadline
  o Phase 2 Requirement Deadline

2025 Roadmap

• Requirements
  o Adverse Events
  o GMP Compliance
  o Safety Substantiation Testing
• Deadlines
  o Phase 3 Requirement Deadline

Q&A and Discussion

• Open floor for questions
• Practical experiences with MoCRA compliance implementation

Conclusion and Recap

• Key Takeaways
• Additional Resources for Further Learning and MoCRA Support