Workshop A – MoCRA Compliance Workshop: A Hands-On Guide to Navigating the Modernization of Cosmetics Regulation Act of 2022

Sep 24, 2024 9:00 am – 12:30 PM

John Fuson
Partner
Kleinfeld, Kaplan & Becker LLP

Mishel Chusid
Founder & Owner
Compliance Regulators

Following its enactment, the FDA has issued a series of guidelines, prompting the industry to prepare for forthcoming deadlines. Our workshop leaders will explore the necessary steps the industry must take to comply with the new framework and meet FDA deadlines.

These new federal standards are reshaping longstanding protocols for adverse event reporting, products and facilities listing, recordkeeping, recalls, safety substantiation, testing methods, GMPs, and more.

Points of discussion will include:

  • Examining the transformative impact of MoCRA on FDA regulations for cosmetics
  • Analyzing the latest MoCRA guidance and expected next steps from the FDA
    • Reviewing the current guidance on product and facility registration
    • Understanding standardized testing
    • GMPs regulations
  • Developing a comprehensive action plan to meet the latest provisions of MoCRA
  • Identifying and procuring the necessary resources needed to implement the next phase of MoCRA requirements
  • Assessing and minimizing the risk of litigation and consumer claims based on the new FDA requirements

Reviewing forthcoming FDA actions:

  • Expected FDA regulations on fragrance allergens to be labelled when they exceed certain concentrations, by June 29, 2024
  • Facility registration and product listing enforcement deadlines by July 1, 2024