During the 11th hour of 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) as part of the Consolidated Appropriations Act. SafetyCall has been closely monitoring the proposed cosmetic legislation for several years and, as anticipated, the MOCRA of 2022 establishes new regulations related to monitoring adverse events and mandatory reporting of all “serious” adverse events (SAERs) associated with cosmetics.
The new law appears to be modeled after 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; medical or surgical procedures required to prevent potentially serious outcomes based on reasonable medical judgment; or birth defects but, goes further with additional definitions related to infections and significant disfigurement. This includes effects described as “significant disfigurement (including serious and persistent rashes, 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 a Part 11 compliant database containing each report of an adverse event, regardless of the level of severity, for a period of six years and FDA inspectors must be allowed access to these records for compliance purposes during audits.
There are additional components of the new law related to good manufacturing practices, registration and mandatory product listing, labeling and recordkeeping requirements, mandatory recall authority, and safety substantiation for cosmetics. Unique to this class of product, there is language specific to “fragrance and flavor ingredients” and how these substances will be monitored for safety.
Although the Act indicates that mandatory reporting for cosmetics is expected to go into effect December 29th, 2023, FDA rulemaking and guidance are still forthcoming which may impact the date enforcement begins.
For full text of the bill, click here.
Now is a good time for manufacturers to review their capabilities and ability to comply with the new requirements. With 19 years of experience providing FDA compliance reporting services, SafetyCall 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. Additionally, SafetyCall also provides a host of expert consulting services addressing product health and safety assessment.
Please reach out to Vice President, Sales, Marketing & Client Services, Katie Michels ([email protected]), should you wish to set up a discussion about mandatory adverse event reporting services or safety substantiation for your cosmetic products.
