Yes, the Act uses "responsible person" as a defined term. On page 619:
RESPONSIBLE PERSON.-The term ''responsible person'' means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.
And yes, a US agent is needed for foreign registrants. On pages 622-623:
(2) CONTENTS.-The registration under subsection (a) shall contain- ... (B) with respect to any foreign facility, the contact for the United States agent of the facility
https://www.govinfo.gov/content/pkg/COMPS-973/pdf/COMPS-973.pdf
I would expect the "responsible person" (manufacturer or distributor) to be a company and not an individual.
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Anne LeBlanc
United States
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Original Message:
Sent: 31-Aug-2023 09:45
From: Victor Mencarelli
Subject: About the MoCRA requirements
Hi Winston.
You would need someone in the US who can be considered the Responsible Party and who would be the initial point of contact for FDA should there be any question or issue that arose with the product(s). It can be an "organization" that is listed on the package if the organization is responsible for receiving information from the consumers at that address and phone number or email.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
Original Message:
Sent: 30-Aug-2023 18:28
From: Winston Costa Pereira
Subject: About the MoCRA requirements
Hello all,
The MoCRA requirements state that the responsible persons name has to be on the label. It can be a manufacturer or a distributor. Is it a person name or is an organizations name that is required?
I reached out to the FDA for clarifications. Does this person Ned to be based in the US or elsewhere like Canada. Just as we have a US agent who has to be based in the US and a responsible person in Europe who has to be based in Europe. Does MoCRA have similar requirements? I guess a responsible person is a person (not an organization).
Kind regards,
Winston Costa Pereira.
Sent from my iPhone