MoCRA (Modernization of Cosmetics Regulation Act of 2022) FAQ

This video answers the most commonly asked questions about the new US cosmetics regulation MoCREA

[@UsmanA.Asghar]

What happens if the contract manufacturer does not have FDA approved facility?

[@ashwinshetty1598]

Hello, could you please shed some light on whether the address of the manufacturing facility based outside the USA is supposed to be mentioned along with the distributor's address on the product label, as the final guidance document doesnt clearly specify whether either one of the addresses or both of them are supposed to be mentioned

[@CewayEu]

No, that is not necessary. The label has to include the name and address of the manufacturer, packer OR distributor.

[@ashwinshetty1598]

Thank you for getting back on such short notice! Although I have another concern! Now that it's established that our manufacturing facility is located overseas and our distributor is US based (they're both part of the same company), can the manufacturing facility handle product listings, while the distributor handles adverse event recording? As they can both be Responsible Persons in this case, can only either one of the addresses be included in the product label even then?

[@CewayEu]

For adverse events, you need to have one of the following on the labels: - US address (this can be your distributor's address if they are the RP and will deal with adverse event reporting) - US phone number (the same as above) - electronic information (eg. website or email) But this is in addition to the name and address of the manufacturer, distributor or packer, that should appear on the labels. Foreign facilities require a US agent, who needs to handle facility registration and communication with the FDA. This can be handled by your US distributor if that is your agreement. The RP is usually the brand owner, but according to the definition it is either the manufacturer, distributor or packer. So it is up to you to define who the RP is in your organization and then that company has the RP responsibilities. You can also share the responsibilities but there has to be one official known RP, who the FDA will contact in case of any inspections.@@ashwinshetty1598

[@ashwinshetty1598]

@@CewayEu And lastly, should we designate our US based distributor as "Responsible Person" on the label outright, or will the contact information and the mail address provided suffice for the General consumer?

[@CewayEu]

@@ashwinshetty1598 RP can't be outsourced in USA, it has to be the brand owner, so a distributor can't be the RP

[@rsh17_WR]

do you have consulting services about cosmetic regulations in Europe and the United States? i just created a bath soap brand in Indonesia, and i am interested in selling my bath soap to Europe/United States.

[@CewayEu]

Yes, we cover Europe (EU and UK) as well as USA and Canada. You can contact us for more info to [e-mail]

[@rsh17_WR]

What if I want to get a certificate of cosmetic regulation in Europe and America even though I don't sell it there for now. the main reason is because of the budget and I want my liquid soap to be completely safe in the lab test of these 2 institutions. I want to have 2 certificates so that I can sell liquid soap at a higher price in Indonesia. because in Indonesia the cosmetics supervision agency is not very strict, even some who get a distribution permit when retested the results are not up to standard and there are many, even some only need to pay money.@@CewayEu