US Agent VS Responsible Person

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA's authority, establishing requirements to ensure the daily safety of consumers and compliance of cosmetic products in the United States. To ensure this compliance, there are two key entities that perform different roles: the Responsible Person and the U.S. Agent.

Responsible Person

The Responsible Person may be the manufacturer, packer, or distributor of a cosmetic product whose name and address are listed on the label and is not required to be based in the U.S. Under MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product marketed in the U.S., who is responsible for:

• Listing each cosmetic product and making annual updates;

• Reporting adverse effects associated with the use of the cosmetic product to the FDA and maintaining records of these reports;

• Keeping records with product information that substantiates its safety;

• Ensuring compliance with labeling requirements;

• Ensuring cosmetic products comply with MoCRA requirements.

When the Responsible Person is not based in the U.S., it is necessary to designate a U.S. Agent.

U.S. Agent

The U.S. Agent is a person or legal entity residing in or having a place of business in the U.S., whose purpose is to serve as the legal representative in the U.S. for companies not based there.

Their responsibilities differ from those of the Responsible Person and include:

• Acting as the point of contact between the FDA and the foreign company;

• Responding to FDA inquiries about products imported into the U.S.;

• Assisting the FDA in scheduling inspections on the foreign company

• Receiving information or documents from the FDA on behalf of the company when the FDA is unable to contact it directly.

If you are not based in the U.S. and intend to export your cosmetic products, Pharmilab can act as your U.S. Agent and provide all the necessary support. Contact us for more information.