The Modernization of Cosmetics Regulations Act of 2022
How We Can Help:
The Modernization of Cosmetics Regulations Act of 2022 (MoCRA) requires cosmetics companies to comply with a host of new regulations, including mandatory adverse event reporting for serious events. As recognized leaders in adverse event management and with nearly 20 years of experience providing FDA compliance reporting services, SafetyCall International is well equipped to provide cosmetic manufacturers assistance with their adverse event reporting obligations, from intake through assessment and report creation by a SafetyCall clinician applying reasonable medical judgment.
What We Know:
The new law is similar to the current dietary supplement and OTC drug mandatory adverse event reporting requirements but adds new definitions for SAERs associated with cosmetic products. Typical of other FDA serious adverse event (SAER) definitions, the new law defines a SAER as an event involving:
- Death
- Life-threatening experiences
- Inpatient hospitalizations
- Persistent or significant disability or incapacitations
- Congenital anomalies
- Birth defects
But goes further with additional definitions including:
- An infection
- Second- or third-degree burns
- Significant hair loss
- Or persistent or significant alteration of appearance
Consistent with supplement and OTC drug requirements, the new law will also require manufacturers to maintain these adverse event records for a period of six years. FDA inspectors must be allowed access to these records for compliance purposes during audits. Since passage of the bill, FDA has announced they will accept these reports to be submitted via MedWatch 3500A and is working on updating the Safety Reporting Portal (SRP) to accommodate electronic submissions of these reports.
What you can do:
Contact us today to explore how SafetyCall can help your organization!