For foreign cosmetic companies seeking access to the U.S. market, appointing a U.S. Agent is not optional it is a mandatory requirement under FDA regulations. Any cosmetic facility located outside the United States that manufactures, packages, or processes cosmetic products for distribution in the U.S. must designate a U.S. Agent. This role is critical because it ensures effective communication between the foreign facility and the U.S. Food and Drug Administration (FDA).

The U.S. Agent acts as the primary point of contact for all FDA-related correspondence. This includes receiving inspection notices, responding to regulatory queries, and facilitating timely communication during compliance reviews. Without a designated agent, foreign facilities may face shipment delays, import refusals, or even loss of market access.

The responsibilities of a U.S. Agent extend beyond being a simple intermediary. They play a strategic role in supporting compliance readiness by ensuring that facilities are informed about regulatory updates, inspection requirements, and enforcement actions. In situations such as FDA inspections, recalls, or product safety concerns, the U.S. Agent must be available 24/7 to coordinate communication and provide immediate support.

At XPRO America, we specialize in offering FDA U.S. Agent Services for foreign cosmetic facilities. Our team serves as your trusted regulatory partner, ensuring constant availability to handle FDA communications. We assist in responding to inspection notices, addressing compliance queries, and guiding businesses through evolving cosmetic regulations under the Modernization of Cosmetics Regulation Act (MoCRA).

By appointing XPRO America as your U.S. Agent, cosmetic companies gain more than just a mandatory representative—they gain a proactive compliance partner. We not only fulfill the FDA requirement but also provide advisory support, helping foreign manufacturers maintain smooth market entry and ongoing operations in the United States.

In today’s competitive cosmetic industry, compliance is a vital component of market credibility. Choosing an experienced U.S. Agent ensures that your business remains accessible, transparent, and aligned with FDA standards.

XPRO America provides FDA U.S. Agent Services for foreign cosmetic facilities, ensuring 24/7 communication, compliance support, and inspection readiness.