In the era of booming global e – commerce, exporting food to the US through cross – border e – commerce presents significant business opportunities. However, the US has stringent regulations and certification requirements for imported food. For businesses aiming to enter this market, understanding and complying with relevant procedures and regulations is the key to success. In the following content, we will comprehensively analyze the detailed process for Cross – border E – commerce Food Exports to the US.

I. Core Regulatory Systems for US – Bound Food Exports in Cross – border E – commerce

FDA Mandatory Registration Requirements: The Threshold for Cross – border E – commerce Food Entering the US

Food Facility Registration (FFR) Process and Exemption Conditions
In the process of exporting food to the US via cross – border e – commerce, the Food Facility Registration (FFR) is the first crucial step. Enterprises need to use the electronic system designated by the FDA to fill in detailed information such as the enterprise name, address, contact information, and the types of food produced. However, not all food enterprises are required to register.

For example, enterprises that are only engaged in food transportation and storage without participating in food processing, as well as certain cross – border e – commerce enterprises that only sell to consumers outside the US and whose products do not circulate within the US, may be exempt. Nevertheless, enterprises must accurately determine whether they meet the exemption criteria. Any misjudgment may lead to compliance risks.

Registration Cycle Update Rules (Renew Every Two Years)
The FDA clearly stipulates that registered food enterprises need to update their registration information every two years. As the business operations of enterprises may change, such as address changes or adjustments to the types of food produced, timely updates enable the FDA to have the latest and accurate information about the enterprises, facilitating effective supervision. Enterprises should plan in advance and complete the update in a timely manner before the registration expires to avoid registration invalidation due to negligence, which may impede the process of exporting food to the US.

Division of Labor among the Three Major Regulatory Agencies: A Tight Network for Regulating Cross – border E – commerce Food

FDA: The Gatekeeper for Reviewing Processed Foods, Additives, and Labels
The FDA plays a central role in the regulatory system of cross – border e – commerce food exports to the US. It is responsible for the strict review of processed foods (excluding meat and poultry), food additives, and food labels. Regarding processed foods, the FDA focuses on examining whether the production process complies with food safety standards. For food additives, it assesses their safety and scope of use. Food labels must strictly follow FDA regulations, accurately indicating key information such as food ingredients, nutritional information, production date, and shelf – life, ensuring that consumers can obtain true and accurate product information.

USDA: The Guardian of Certification for Meat, Poultry, and Egg Products
The United States Department of Agriculture (USDA) is mainly responsible for the certification of meat, poultry, and egg products. If cross – border e – commerce involves the export of such foods to the US, a series of strict standards set by the USDA must be met. These standards cover aspects such as feed and drug use regulations during animal breeding, hygienic conditions during slaughtering and processing, as well as product packaging and storage requirements, to ensure that US consumers can purchase safe and high – quality related foods.

FSIS: The Sharp Blade for Special Inspections of Imported Meat
The Food Safety and Inspection Service (FSIS) focuses on special inspections of imported meat. When cross – border e – commerce exports meat products to the US, the FSIS will conduct strict tests on the meat, including microbial testing, veterinary drug residue testing, and other aspects. Only meat products that pass the strict inspections of the FSIS can enter the US market. This measure aims to keep unqualified meat products out and fully protect the health of US consumers.

Special Product Certification Systems: The Certification Keys for Special Cross – border E – commerce Foods

FCE Registration and SID Filing for Low – Acid Canned Foods (LACF)
Low – acid canned foods are a special category in cross – border e – commerce food exports to the US. They require FCE (Factory Registration for Low – Acid Canned Foods) registration and SID (Schedule of Processing Filing) filing. For FCE registration, enterprises need to provide detailed factory information, production processes, quality management systems, etc.

After passing the FDA’s review, the enterprise will obtain the FCE registration number. SID filing, on the other hand, is for the sterilization equipment used in the production of canned foods. Information such as the equipment model, manufacturer, and operating parameters needs to be reported to the FDA to ensure that the sterilization process meets safety standards and guarantees the quality and safety of low – acid canned foods.

GMP On – site Inspection for Infant Formula
Infant formula is of great significance for the healthy growth of infants, and the FDA’s supervision of it is extremely strict. In addition to meeting general food requirements, it also needs to undergo a GMP (Good Manufacturing Practice) on – site inspection. The inspection covers many aspects, including the hygiene conditions of the production workshop, the cleaning and maintenance of production equipment, the health and hygiene management of employees, and the procurement and inspection of raw materials. Only after successfully passing the GMP on – site inspection and proving that the enterprise’s production process meets strict quality standards can the infant formula produced be exported to the US.

II. Full – link Operational Process for B2B Sellers in Cross – border E – commerce Food Exports to the US

Pre – qualification Preparation Phase: The Starting – line Preparation for B2B Sellers in Cross – border E – commerce

Necessity of Obtaining a DUNS Number
For B2B sellers in cross – border e – commerce, obtaining a DUNS (Data Universal Numbering System) number is essential. The DUNS number serves as a global business identity identifier for enterprises and plays an important role in many aspects of cross – border e – commerce food exports to the US. For example, in the FDA registration process, in some cases, the DUNS number needs to be filled in, which helps the FDA accurately identify and manage enterprise information. Moreover, when conducting business with US partners, they may also require the provision of the DUNS number to evaluate the reputation and strength of the enterprise.

Paths to Obtain the FDA Registration Number and FEI Number for Enterprises
To obtain the FDA registration number and FEI (Facility Identification Number), enterprises need to submit an application through the FDA’s official electronic registration system. Fill in the relevant enterprise information truthfully according to the system’s instructions and complete the registration application process. After passing the review, the enterprise will obtain these two important numbers, which are key identifiers of the enterprise in the FDA system and play a crucial role in subsequent links of food exports to the US, such as customs clearance and product traceability.

Product Compliance Breakthrough: The Key to Cross – border E – commerce Foods Meeting US Standards

Mandatory Specifications for Nutrition Label (NLEA) Format
For foods exported to the US via cross – border e – commerce, their nutrition labels must strictly comply with the mandatory specifications of the NLEA (Nutrition Labeling and Education Act) format. The nutrition label should clearly indicate the content of nutrients such as energy, protein, fat, carbohydrates, and sodium in the food, as well as the percentage of these nutrients in the daily recommended intake. In addition, details such as the font size, color contrast, and layout of the label also have clear requirements to ensure that consumers can clearly and accurately obtain the nutritional information of the food.

Standards for Allergen Declaration and Warning Labeling
The US has strict management of food allergens. Foods exported via cross – border e – commerce must be labeled with allergen declarations and warning labels in accordance with the standards. Common allergens such as milk, eggs, peanuts, nuts, and wheat, if contained in the food, must be clearly labeled in a prominent position on the label, allowing consumers to see at a glance, avoiding allergic reactions and effectively protecting the health and safety of consumers.

Special Handling of Cross – border Logistics: Measures to Ensure the Transportation of Cross – border E – commerce Food

PSP Transportation Agreement for Cold – chain Foods
For the cross – border e – commerce export of cold – chain foods to the US, signing a PSP (Public Health Service) transportation agreement is of great significance. This agreement clearly stipulates key aspects such as temperature control, equipment maintenance, and hygiene standards during the cold – chain transportation process, ensuring that cold – chain foods are always in a suitable temperature environment during transportation, guaranteeing food quality and safety, and preventing food spoilage due to factors such as temperature fluctuations.

Temporary Storage Strategy in US Customs Bonded Warehouses
US Customs bonded warehouses provide a flexible temporary storage strategy for cross – border e – commerce food exports. When foods arrive at US ports, if they cannot be cleared through customs or transferred in a timely manner due to various reasons, they can be stored in bonded warehouses. In the bonded warehouse, the foods can be temporarily exempt from paying tariffs until relevant conditions are met and further arrangements can be made. This provides a buffer time for enterprises, facilitating them to properly handle customs clearance procedures or plan subsequent logistics and distribution.

Key Control Points for Customs Clearance: Highlights for Smooth Customs Clearance of Cross – border E – commerce Food

Submission Time Limit of PRIOR NOTICE (Advance Notice System)
The PRIOR NOTICE (Advance Notice System) is a key link in the customs clearance of cross – border e – commerce food exports to the US. Enterprises must submit relevant notice information to the FDA before the food arrives at the US port within the specified time limit, including detailed descriptions of the food, quantity, origin, and estimated arrival time. The submission time limit varies according to the mode of transportation. For example, for sea transportation, it usually needs to be submitted five working days in advance. Missing the submission time limit may result in the food not being able to pass customs smoothly and may even lead to penalties.

Response Plan for FDA Sampling Inspection
The FDA may conduct sampling inspections on imported foods. If an enterprise encounters this situation, it should cooperate actively. First, ensure the provision of accurate and complete product information and relevant documents, such as production records and inspection reports. If the test results are unqualified, the enterprise needs to carefully analyze the reasons, take targeted corrective measures, such as improving the production process and adjusting the product formula, and resubmit the test application according to the FDA’s requirements until the product passes the test and customs clearance is successfully completed.

III. Pit – avoiding Guide for High – risk Categories in Cross – border E – commerce Food Exports to the US

Plant – based Foods: Precautions for Exporting Plant – based Foods to the US in Cross – border E – commerce

Organic Certification (NOP) and USDA Green Label
When cross – border e – commerce exports plant – based foods to the US, if the products claim to be organic, they must obtain the National Organic Program (NOP) certification and can use the USDA green label. The NOP certification requires enterprises to strictly follow organic production standards, from soil management, fertilization to pest control, all links need to meet organic requirements. After obtaining the certification, the products can enhance their market competitiveness with the USDA green label. However, enterprises need to continuously maintain their production processes in line with organic standards and accept regular inspections.

Pesticide Residue Limits (EPA 40 CFR 180)
The pesticide residues in plant – based foods must comply with the standards set by the US Environmental Protection Agency (EPA) in 40 CFR 180. During the planting process, enterprises should strictly control the use of pesticides, select pesticides that meet the regulations, and apply them in the correct dosage and method. Before export, the products need to be tested to ensure that the pesticide residue levels are within the specified limits to avoid product rejection or penalties due to exceeding the standard.

Animal – based Foods: Key Points for Exporting Animal – based Foods to the US in Cross – border E – commerce

Issuance of a Foot – and – Mouth Disease – free Area Certificate
For the export of animal – based foods to the US, a foot – and – mouth disease – free area certificate is a necessary document. Enterprises need to apply to the local relevant department for the issuance of this certificate to prove that the product source is a foot – and – mouth disease – free area. This is to prevent the introduction of foot – and – mouth disease and other diseases into the US and protect the safety of the US livestock industry. During the certificate issuance process, relevant breeding records, disease detection reports, and other materials need to be provided to ensure the authenticity and effectiveness of the certificate.

Template for Hormone Use Declaration Documents
Regarding the use of hormones in animal – based foods, the US has strict regulations. Enterprises need to provide hormone use declaration documents, detailing whether hormones are used during the breeding process of the products and the specific usage. They can refer to the declaration document templates provided by the official or industry, fill in the information truthfully, so that US regulatory authorities and consumers can clearly understand the hormone use situation of the products and meet US regulatory requirements.

Special Specifications for Prepared Foods: Special Requirements for Exporting Prepared Foods to the US in Cross – border E – commerce

Scope of Mandatory Implementation of the HACCP Plan
For prepared foods in cross – border e – commerce food exports to the US, some products are required to mandatorily implement the HACCP (Hazard Analysis and Critical Control Points) plan. The HACCP plan requires enterprises to conduct a hazard analysis of each link in the production process of prepared foods, determine critical control points, and formulate corresponding preventive and control measures to ensure the safety and hygiene of the food. Enterprises should reasonably formulate and effectively implement the HACCP plan according to the characteristics of the products and the production process.

Special Requirements for Irradiated Food Labels
If the prepared foods exported via cross – border e – commerce have been irradiated, there are special requirements for the labels. The words “irradiated treatment” must be clearly marked on the label to inform consumers of this treatment method. At the same time, information such as the purpose of irradiation and the irradiation dose range needs to be marked, allowing consumers to fully understand the product situation and comply with US regulations on irradiated food labels.

IV. Digital Transformation Solutions for Cross – border E – commerce Food Exports to the US

Practical Operation of the FDA Electronic Submission System (FURLS): A Convenient Channel for Cross – border E – commerce Food Exports

The FDA Electronic Submission System (FURLS) provides a convenient submission channel for cross – border e – commerce food exports to the US. Enterprises can submit various applications and documents online through this system, such as FDA registration applications and FCE registrations for low – acid canned foods. During the practical operation, enterprises need to fill in the information accurately according to the system’s prompts and upload clear and complete documents. After submission, they can query the application progress and results through the system in real – time, which greatly improves work efficiency and reduces the cumbersome process of paper document submission.

Recommendations for Automated Compliance Platform Tools: Facilitating the Compliant Export of Cross – border E – commerce Food to the US

TraceGains Supplier Management System
The TraceGains Supplier Management System helps cross – border e – commerce enterprises effectively manage the compliance affairs of food exports to the US. This system can comprehensively evaluate and manage suppliers to ensure that the supply of raw materials complies with US regulatory requirements. At the same time, it can track the entire process of products from raw material procurement to finished product export, assist enterprises in timely discovering and solving compliance problems, and enhance the transparency and controllability of the supply chain.

SAP S/4HANA Compliance Module
The SAP S/4HANA Compliance Module provides an integrated compliance module solution for enterprises. It integrates the data of various internal enterprise links such as production, procurement, and sales, and conducts compliance inspections and analyses according to US food regulations. For example, it can generate and review nutrition labels, manage allergen declarations, etc., ensuring that all business operations of the enterprise comply with the regulatory requirements for cross – border e – commerce food exports to the US.

Application Cases of Blockchain Traceability Technology: A Tool to Enhance the Credibility of Cross – border E – commerce Food

Implementation Path of IBM Food Trust
IBM Food Trust is a model application of blockchain traceability technology in the food industry. In the process of cross – border e – commerce food exports to the US, enterprises can use this platform to achieve full – process traceability of food. Starting from the food production source, information from all links such as planting, breeding, processing, transportation, and sales is uploaded to the blockchain.

Utilizing the non – tamperable characteristics of blockchain, the authenticity and integrity of the information are ensured. Consumers and regulatory authorities can quickly query the detailed information of the food through the platform, improving the credibility of the food and enhancing consumers’ confidence in imported foods.

V. Violation Risk Response System for Cross – border E – commerce Food Exports to the US

Process for Lifting an Import Alert: Strategies for Cross – border E – commerce to Respond to Import Alerts

If an import alert is received during the process of cross – border e – commerce food exports to the US, the enterprise needs to respond actively to lift the alert. First, deeply understand the reasons for the alert and carry out targeted rectification. For example, if it is a product label problem, promptly modify the label and resubmit it for review; if it is a product quality problem, improve the production process and retest the product.

After the rectification is completed, collect relevant supporting materials, such as rectification reports and test – passing reports, submit an application to the FDA to lift the import alert, maintain close communication with the FDA, and cooperate with its investigation to strive to lift the import alert as soon as possible.

Key Points for Preparing for an FDA Hearing after Seizure: Keys for Cross – border E – commerce to Respond to FDA Seizures

When food is seized by the FDA and a hearing is impending, the enterprise needs to be fully prepared. Collect and organize all product – related materials in advance, including production records, inspection reports, and compliance certificates, to prove that the product complies with US regulations. Form a professional response team, which may include lawyers, food experts, etc., analyze possible problems and develop response strategies. At the hearing, clearly and accurately present the enterprise’s viewpoints and evidence, and actively strive for a favorable outcome.

Selection of the Voluntary Destruction (VD) Alternative: Choices for Cross – border E – commerce to Respond to Product Violations

If a product is facing FDA requirements for destruction due to serious violations, the company may consider voluntary destruction (VD) as an alternative. Before choosing this option, it is necessary to evaluate the severity of the product violation and the possibility of rectification. If the cost of rectification is too high or it is impossible to rectify, voluntary destruction can prevent the company from facing more severe penalties, such as high fines, export bans, etc. However, the company must perform voluntary destruction operations in accordance with FDA procedures, ensure compliance with the destruction process, and retain relevant records.