The Modernization of Cosmetics Regulation Act 
On December 29, 2022 the Consolidated Appropriations Act 2022 was signed into law giving the FDA more authority over the safety of cosmetics.
​Requirements of MoCRA
Adverse Event Recording 
  • Any adverse event reported by consumers need to be recorded and maintained for 6 years (3 years for small businesses) by the appointed Responsible Person. 
  • Any Serious Adverse Events must be reported to the FDA no later than 15 business days after receiving the information of the event.  o Tracking and reporting needs to begin as of December 29,2023.

Product & Facility Registrations
  • FDA Direct is the database for all Product Listing and Facility Registrations. This Platform is also used for CDER direct registrations, a combined account can be made if a brand has both cosmetic and OTC products. 
  • All products must be registered within the database by July 1st, 2024. These listings need to be updated annually. 
  • Cosmetic Manufactures must register their facilities within the FDA database by July 1st, 2024, any changes must be reported within 60 days and renewal of registrations every two years.  
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Responsible Person
  • This can be the Manufacturer, Brand, distributor, or a third party whose name appears on the packaging of products. This person should be the same as the one who records all Adverse Events.   

Cosmetic Labeling Requirement  
  • A cosmetic is defined by the FDA as “Articles intended to be rubbed, poured, sprinkled, or sprayed introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” False or misleading claims or inaccurate information is prohibited by the FDA. The lines between a cosmetic and a drug can often become blurred to the untrained eye. Making false and or misleading claims can result in action from the FDA. 
  • MoCRA brings new label requirements such as allergen declaration, use statements for professionals, and adverse event contact on the label. ​ 
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How Can First Impact Help?
Responsible person/ Agent services
  • First Impact team can advise and help build out a tracking system for all Adverse Health and Serious Adverse events, to be able to report to the FDA in the event of a Serious Adverse Event. Please note if the Facility is outside U.S territory a U.S Agent will be required to hold all paperwork on their behalf.  ​
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Facility Registration
  • The First Impact team will create a username on the CM behalf, will fill out all registration documents, submit required documentation to the FDA for publication. 
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Cosmetic Product Listing
  • Our First Impact team will create a username login for cosmetic registration, CDER Direct registration or a combination or both if the brand has cosmetics and OTC products. Will gather all required documents for submission with the registration for publication. 

Cosmetic Label Review
  • First Impact team will gather all labels, claims, and supporting data from the brand, at this time review will begin to ensure that claims are compliant with current standards for cosmetic or OTC definitions. Recommendations will be suggested if rework of claims or packaging is needed. 
Check out the FDA Website for additional information

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