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US AGENT FOR
THE UNITED STATES
In the United States, the " US Agent " is a relevant figure for foreign cosmetic product manufacturers wishing to market their products in the country. The "US Agent" acts as the local representative in the US for these manufacturers, serving as a point of contact between the Food and Drug Administration ( FDA ) and the foreign company.
WHO IS THE US AGENT?
A US Agent is a natural or legal person resident in the United States designated by a foreign cosmetic product manufacturer. This agent is required by the FDA to facilitate communications and serve as a liaison on matters related to FDA compliance, inspections, and other regulatory matters.
US AGENT FOR FOREIGN MANUFACTURERS
The designation of a US Agent is a crucial requirement for any cosmetics manufacturer located outside the United States and wishing to market their products in the US market. Without a US Agent, the FDA will not allow the products to be imported, as they would lack a reliable contact within the country to handle any issues related to product compliance and safety.
REQUIREMENTS FOR A US AGENT
US Residency : The US Agent must be located in the United States, either as a natural entity (person) or a legal entity (company).
Availability : The US Agent must be available during business hours to respond to FDA requests. This includes being available to respond to urgent communications.
Regulatory Knowledge: Although not a formal requirement, it is beneficial for the US Agent to have a good understanding of FDA regulations and the cosmetics market in order to serve effectively as an intermediary.
ROLES AND RESPONSIBILITIES
FROM A US AGENT
01
Point of Contact with
the FDA
The US Agent acts as an intermediary between the foreign manufacturer and the FDA. The FDA will contact the US Agent regarding any issues related to product compliance, including requests for documentation, questions about manufacturing practices, and inspection management.
It is essential that the US Agent be available during normal business hours to receive and respond to FDA communications.
02
Inspection Management
The US Agent may be contacted by the FDA to coordinate inspections of the foreign manufacturer's facilities. This is part of the FDA's effort to ensure that imported products meet U.S. safety and quality standards.
Although the US Agent is not responsible for the facility itself, it is their duty to facilitate communication and coordinate responses between the FDA and the manufacturer.
03
Reception of Documentation and Notifications
The FDA will forward any official correspondence, such as warning letters or requests for additional information, to the US Agent. It is the US Agent's responsibility to ensure this information is promptly transmitted to the foreign manufacturer.
The US Agent may also receive requests for immediate action from the FDA, such as notifications of product safety problems.
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