MoCRA Updates

by | Sep 20, 2023 | Cosmetics, MoCRA, U.S. Regulatory

On Friday, Sep. 15, 2023, the FDA posted draft screenshots of the electronic submission portal – Cosmetics Direct – that will enable companies to organize and compile information needed to file facility registration and product listing submissions come Oct. 2023.  While the electronic submission process is preferred to facilitate efficiency and timeliness of data submission, companies also have an option to submit paper facility registrations (using Form FDA 5066) and product listings (using Form FDA 5067).

What you need to know:

  • Cosmetics Direct is part of a larger portal known as FDA Direct (previously CDER Direct).
    • If you previously held a CDER Direct Account, you are likely to already have access to FDA Direct. However, you may need to obtain access to Cosmetics Direct. This is yet to be confirmed.
    • First Time Users will need to sign up by selecting ‘Create New Account ‘.
  • An account will be needed for your company, but you will be able to add multiple users, who would be able to assist with compilation and filing of your facility registration and/or product listings.
  • For Facility Registrations, the following are mandatory fields:
    • Facility Name, FEI No., Street Address, City, State/Province, Country, Zip/Postal Code, Email, Phone No., Name of the Owner and/or Operator of the Facility
    • For foreign companies: US Agent Name, Phone No., Email
    • Brand names of cosmetics manufactured or processed at the facility, the respective Responsible Person (as listed on the label) and the product category
  • For Product Listings, the following are mandatory fields:
    • Responsible Person Name (as listed on label) and Phone No.
    • Product Name, confirmation of whether it contains Fragrance or Flavor, Product Category Code, Ingredient UNII Name
      • You will be able to enter each ingredient separately or upload a prefilled ingredients file.  Details of what this file should contain are not yet available.
    • Manufacturing/Processing Facility Name, Street Address, City, State/Province, Country, Zip/Postal Code, Confirmation of if it is a small business, FEI Number

You may view the draft content released for comments by the FDA here or here. If you have any questions at all, please do not hesitate to reach out.