The US FDA has published new information regarding the MOCRA facility registration and product listing requirements, including:

  • screenshots/overview of the electronic submission portal (“Cosmetics Direct”) [this is not online yet, expected in October]
  • how to obtain a “FDA Establishment Identifier (FEI)” for your business (which will be required prior to registering your facility through “Cosmetics Direct” [this can be done now]
  • drafts of the electronic/paper forms (can be used but electronic submissions are highly encouraged)
  • request for comments from stakeholders on the above.

If your company requires any assistance in getting ready for these MOCRA requirements, please reach out directly!

RegTox can support your MOCRA requirements:

  • obtaining FEI
  • facility and product listing
  • agent support