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 the compliance of cosmetic products in the United States. To ensure this compliance, there are two key entities that perform different functions: the Responsible Person and the US Agent.
Responsible Person
The Responsible Person may be the manufacturer, packager, or distributor of a cosmetic product whose name and address appear on the label, and is not required to be based in the US. Under MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product placed on the US market, who is responsible for:
• Listing each cosmetic product and making the respective annual updates;
• Reporting adverse effects associated with the use of the cosmetic product to the FDA and maintaining records of these reports;
• Maintaining records with product information that supports its safety;
• Ensuring compliance with labeling requirements;
• Ensuring compliance of cosmetic products with MoCRA requirements.
When the Responsible Person is not based in the US, they must appoint a US Agent.
US Agent
The US Agent is a person or legal entity residing or having an address in the US, with the purpose of being the legal representative in US territory for companies that are not based there.
Their responsibilities are different from those of the Responsible Person and include:
• Being the point of contact between the FDA and the foreign company
• Responding to questions from the FDA regarding products imported into the US;
• Assisting the FDA in scheduling inspections of the foreign company's facilities;
• 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 US and wish to export your cosmetic products, Pharmilab can be your US Agent and provide all the necessary support. Contact us for more information.