Requirements and Documents for Exporting to the U.S.: A Complete Guide for Entrepreneurs

The United States is the second-largest importer in the world, with over $3.1 trillion in annual imports. In 2024 alone, Colombian exports to the U.S. reached $20.8 billion, with food, chemicals, and technology leading the sales.

To take advantage of this growing market, it is essential to understand the legal requirements and documents needed for product entry into the U.S. Compliance with these regulations not only ensures a smooth export process but also opens doors to new business opportunities.

1. Key Requirements for Exporting to the U.S.

Before shipping products to the U.S., businesses must comply with specific regulations, depending on the type of product. The following agencies regulate exports:

• FDA (Food and Drug Administration): Regulates processed foods, beverages, supplements, cosmetics, and medical devices.
• USDA (United States Department of Agriculture): Oversees agricultural products and processed foods.
• CBP (Customs and Border Protection): Enforces customs and border security regulations.

📌 For more information on FDA registration, visit our guide: FDA Registration: Key to Exporting to the U.S.

2. Essential Documents for Exporting to the U.S.

To ensure smooth entry of your products into the U.S., you must present the following mandatory documents:

2.1 Commercial Invoice

The main document that describes the goods, their value, and sales conditions. It must include:
✔ Exporter and importer details
✔ Detailed product description
✔ Unit price and total cost
✔ Payment and shipping terms

2.2 Packing List

Provides detailed information about the shipment’s contents, specifying quantities, weights, and dimensions.

2.3 Certificate of Origin

Certifies the country of origin of the product and is required to benefit from free trade agreements, such as the U.S.-Colombia Trade Agreement.

2.4 FDA and USDA Registration (for Food and Beverages)

Exporters of food products must register their company and products with the FDA and, in some cases, comply with additional USDA requirements.

📌 For details on the USDA process, check out: USDA Registration Guide.

2.5 Bill of Lading (BOL)

Issued by the shipping company, this document is essential for maritime transportation of goods.

2.6 Import Declaration (CBP Form 7501)

An official customs declaration form required by CBP for goods entering the U.S.

2.7 Labeling and Compliance Requirements

Many products require specific labeling in English, detailing ingredients, safety information, and usage guidelines.

📌 For industry-specific requirements, check out: How to Export Food to the U.S. from Colombia.

3. Step-by-Step Process for Exporting to the U.S.

Step 1: Research Applicable Regulations

Determine whether your product requires FDA, USDA, or CBP approval.

Step 2: Register Your Business and Product

Obtain the necessary permits and registrations with agencies like the FDA and USDA.

Step 3: Prepare Customs Documentation

Ensure you have the commercial invoice, packing list, and certificate of origin ready.

Step 4: Choose a Shipping Method and Customs Broker

Decide whether to ship via air, sea, or land, and select a reliable customs broker.

Step 5: Ship Your Goods and Monitor the Process

Track your shipment and ensure it meets all U.S. entry requirements.

4. Benefits of Exporting to the U.S.

✔ Access to a High-Consumption Market: The U.S. is the world’s largest importer and has one of the most dynamic economies.
✔ Free Trade Agreements: Countries like Mexico, Colombia, and Ecuador have agreements that reduce export costs.
✔ Growth Opportunities for Latin American Businesses: Exporting to the U.S. allows companies to expand and increase profitability.

📌 For more information on international exports, read our guide: Exports from Mexico, Colombia, and Ecuador to the U.S. in 2025.

5. How Can We Help?

At Prodezk, we simplify the export process, ensuring you comply with all legal and logistical requirements.

✔ Assistance with FDA and USDA Registration
✔ Management of Customs Documentation
✔ Compliance with Export Regulations

Want to export to the U.S. without complications? Contact us for a personalized consultation.

📌 Explore more export resources:

• FDA Registration: Key to Exporting to the U.S.
• How to Export Products from Ecuador to the U.S.