What FDA import requirements and registration steps should a Chinese food company follow to export to the U.S. market?

Dear Sir/Madam,

With respectful greetings, the following is a brief overview of the main FDA and U.S. import requirements your Chinese food company should address before exporting products to the United States.

FDA registration
Any foreign facility that manufactures, processes, packs, or stores food for consumption in the United States must register with the U.S. Food and Drug Administration (FDA) before exporting. Registration is done online and must include a unique facility identifier (currently a D‑U‑N‑S number), full facility details, product categories, and the contact information of your designated U.S. agent. FDA food‑facility registrations must be renewed every even‑numbered year between October 1 and December 31, and you must update the registration when key information (such as address or U.S. agent) changes.​

Compliance obligations
In addition to registration, your facility must produce food that is safe, not adulterated, and manufactured under sanitary conditions and food‑safety controls that meet U.S. standards (for example, good manufacturing practices and preventive controls under the Food Safety Modernization Act). On the U.S. side, the “FSVP importer” (usually the U.S. owner or consignee of the food at the time of entry, or your U.S. agent if there is no U.S. owner at entry) must develop, maintain, and follow a Foreign Supplier Verification Program for each product and supplier, including hazard analysis, supplier evaluation, verification activities, and detailed recordkeeping. If your products contain meat, poultry, or egg products, they may also be subject to separate USDA/FSIS import rules requiring that such products come from approved countries and establishments and meet additional inspection conditions.​

Labeling and documentation
All imported foods must be accompanied by labeling that is truthful, not misleading, and informative, so that consumers can understand what the product is and how to use it safely. In practice, this usually means labels in English that show the statement of identity (product name), net quantity, name and address of the manufacturer/packer/distributor, full ingredient list in descending order by weight, Nutrition Facts panel, allergen declarations, and a clear “Product of China” or similar country‑of-origin marking on the product or its packaging. Before each shipment, your broker or U.S. partner must submit Prior Notice to FDA electronically, providing shipment and product details within the required timeframe—typically up to 15–30 days before arrival, but at least several hours before the goods reach the U.S. port, depending on the system used and transport mode.​

U.S. agent, timelines, and support
Every foreign food facility is required to appoint a U.S. agent with a physical U.S. address, who serves as the primary contact point for FDA regarding registration, routine communications, and emergencies. Once you have your D‑U‑N‑S number and all information ready, food‑facility registration and issuance of an FDA registration number can often be completed in a few days to about one to two weeks, and some service providers report obtaining numbers in less than 48 hours after submission. For each shipment, Prior Notice can be filed up to 15–30 days before arrival, and if documentation and labeling are correct, customs and FDA clearance may take less than a day, although random holds or inspections can extend this to several days or, in more complex cases, a week or more.​

Because these rules are technical and product‑specific, the above is only a general overview and not formal legal advice.

Hello

Thank you for your inquiry. We understand you are seeking clarity on the U.S. FDA import requirements for exporting your food products to the United States. We can certainly provide you with the necessary information and guidance to navigate this process successfully.

Below is a summary of the key FDA requirements and registration steps for a Chinese food manufacturer.

FDA Facility Registration
Before your food products can be imported into the U.S., your manufacturing, processing, packing, or holding facility must be registered with the FDA. This registration is a mandatory requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.​

Registration Renewal: The registration must be renewed every two years.​

Unique Facility Identifier (UFI): As of October 1, 2020, all registered facilities must have a UFI recognized by the FDA.​

Appointment of a U.S. Agent
All foreign food facilities must designate a U.S. agent who is located in the United States. This agent serves as a communication link between the FDA and your company and must be available 24/7.​

Food Safety and Compliance
Your products must meet the same food safety standards as domestically produced foods in the U.S.. This includes compliance with the Food Safety Modernization Act (FSMA), which has several key rules for foreign suppliers:​

Preventive Controls for Human Food: This rule requires food facilities to have a food safety plan in place that includes a hazard analysis and risk-based preventive controls.

Good Manufacturing Practices (GMPs): You must adhere to the FDA's GMPs for food manufacturing, processing, and holding.​

High-Risk Foods: For certain high-risk foods, the FDA may require a third-party certification or other assurances of compliance.​

Labeling Requirements
U.S. food labeling regulations are extensive and must be strictly followed to avoid detention of your products at the port of entry. Key labeling requirements include:​

Nutrition Facts Label: Most packaged foods are required to have a Nutrition Facts label [, web-9]. The FDA updated the label in 2016 to include information on added sugars, Vitamin D, and potassium.​

Front-of-Package Labeling: The FDA has proposed a new rule for a front-of-package nutrition label that would display key nutritional information to consumers.​

Ingredient and Allergen Labeling: Ingredients must be listed in descending order of predominance by weight, and major food allergens must be declared.​

Language: All mandatory label information must be in English.​

Prior Notice of Imported Foods
The FDA requires prior notice for all food shipments imported into the U.S.. This notice must be submitted electronically to the FDA and confirmed before the shipment arrives at the first U.S. port.​

Submission Timeline:

By Sea: At least 8 hours before arrival.​

By Air or Rail: At least 4 hours before arrival.​

By Road: At least 2 hours before arrival.​

Submission Systems: Prior Notice can be submitted through the FDA's Prior Notice System Interface (PNSI) or the U.S. Customs and Border Protection's (CBP) Automated Broker Interface/Automated Commercial System (ABI/ACS).​

Submission Window: You can submit the Prior Notice up to 15 calendar days before arrival via PNSI, or up to 30 calendar days before arrival via ABI/ACS.​

We understand that navigating these regulations can be complex. We are available to provide you with detailed, step-by-step guidance through a paid text consultation on WhatsApp to ensure your company is fully compliant with all FDA requirements. Please let us know if you would like to schedule a consultation.

Sincerely,