Hong Kong → US: Food U.S. Agent
Hong Kong-based food facilities registered under the Bioterrorism Act and FSMA that export to the United States are required by FDA to designate a U.S. Agent. Assurentry provides fast, reliable U.S. Agent representation for companies in Hong Kong.
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Why Hong Kong Companies Need a U.S. Agent
Under U.S. federal law, every foreign facility that manufactures, processes, packs, or holds food for export to the United States must designate a person residing or maintaining a place of business in the U.S. as their agent.
For companies in Hong Kong, this means appointing a U.S.-based representative who can receive FDA communications, assist with inspections, and act as your point of contact with the agency. Without a valid U.S. Agent, your FDA registration is incomplete and your products may be refused entry at U.S. ports.
Assurentry has extensive experience serving food companies from Hong Kong and throughout the east asia region. We understand the specific regulatory challenges your business faces and provide responsive, knowledgeable support.
What's Included for $399/year
21 CFR 1.227 — Food U.S. Agent Requirement
The FDA regulation 21 CFR 1.227 requires all foreign food establishments to designate a U.S. Agent as part of their facility registration. Here is what that means for your Hong Kong-based business.
Regulatory Authority
The U.S. Agent requirement is established under 21 CFR 1.227 and enforced by the U.S. Food and Drug Administration (FDA). Compliance is mandatory for all foreign facilities in the food category.
Agent Responsibilities
Your U.S. Agent receives FDA communications on your behalf, assists with FDA inspections of your facility, helps respond to questions from FDA, and serves as an emergency point of contact for recalls or safety issues.
Consequences of Non-Compliance
Facilities without a valid U.S. Agent cannot complete their FDA registration. This can result in import refusals, shipment detentions at U.S. ports, FDA warning letters, and loss of market access.
Need help exporting food from Hong Kong?
Our regulatory experts guide international companies through every step of FDA registration and U.S. Agent appointment.
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Appoint Assurentry as your U.S. Agent today for just $399 per year. We'll file the designation with FDA and provide your acceptance letter within one business day.
Trusted by 2,800+ companies in 160+ countries