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FDA 101: Stay Compliant with U.S. FDA Shipping Regulations

When shipping goods into the United States such as food, cosmetics, or medical devices, shippers must follow U.S. Food and Drug Administration (FDA) regulations. These rules protect U.S. consumers and ensure that all imported products meet U.S. safety standards.

At ShipNerd, we know that international and export shipping can get complicated when compliance is involved. Missing one document or using an incorrect product description could lead to delays, penalties, or even refusal of entry at the border. This article breaks down the basics exporters need to know about shipping FDA-regulated products to the U.S. the right way.

🚨 NERD ALERT! This article is intended as an overview guide to help shippers understand general FDA requirements for U.S.-bound shipments. It is not an all-encompassing resource, and specific products may require additional documentation or procedures. ShipNerd is not a customs broker, and the information provided here may not cover every situation or product classification. Shippers are encouraged to consult a licensed customs broker or compliance specialist for personalized guidance on their specific shipments.

Why FDA Compliance Matters for Export Shipping

The FDA closely inspects and reviews shipments to ensure they meet U.S. import and labeling laws. If your shipment includes any regulated items, incomplete or inaccurate documentation can cause:

• Customs delays
• Fines or penalties
• Product seizure or destruction
• Refusal of entry or abandonment

Following the correct international shipping process protects both your business and your customers.

Step 1: Determine if FDA Regulation Applies

If your shipment contains any of the following, FDA rules apply:

• Food items (for human or animal consumption)
• Cosmetics and personal care products
• Medical devices or optical products

Knowing whether FDA oversight applies is the first step toward smooth clearance and compliance. FDA customs clearance is not considered “routine”, so typically additional brokerage fees may apply.

Step 2: Prepare the Required Documentation

Accurate documentation is critical for all U.S.-bound exports. You’ll need:

• A commercial invoice written in English, listing product description, value, and country of manufacture (this is provided electronically when you create your export shipment on ShipNerd)
• Manufacturer’s name and address
• Any required identification or registration numbers (depending on product type)

Even minor errors can trigger customs reviews or secondary inspections.

Step 3: File a Prior Notice (PN) with the FDA

For all food shipments, exporters must file a Prior Notice (PN) with the FDA before the shipment reaches the border.

You can file this through the Prior Notice System Interface (PNSI) and include the PNSI number with your shipping documents. This can be attached as an uploaded file using ShipNerd’s document upload tool or added to the commercial invoice’s reference or comments section.

Learn more at the FDA Prior Notice System.

FDA Requirements by Product Type

Food Shipments (HTS Chapters 7–23, 25)

• Labels must be in English
• Include complete product description, country of manufacture, and value
• State the manufacturer’s name and address
• File a Prior Notice (PN) for all food (human or animal)
• Provide or attach the PNSI number for quicker processing

Cosmetic Shipments (HTS Chapters 33, 3401, 9616)

• Labels and invoices must be in English
• Include:
  • Full description, value, and country of manufacture
  • Product Identification Number
  • Manufacturer’s name and address
• If the shipment includes branded or patented products, provide an authorization letter from the brand owner (if not being shipped by the brand owner)

Medical Device Shipments (HTS Chapter 90)

• Labels must be in English
• Include the following information:
  • Manufacturer FDA Registration Number
  • Exporter FDA Registration Number
  • Manufacturer’s name and address
  • Medical Device Listing Number
  • 510(k) PMN Number (if applicable)
  • FDA product code
  • Intended use by importer
• Shipments containing sunglasses or lenses must include an Impact Resistance (Drop Ball) Certificate

More details can be found on the FDA Device Registration and Listing page.

Avoid Shipping Delays with ShipNerd

Whether you’re managing international exports or expanding into the U.S. market, ShipNerd helps simplify the process. Our platform connects you with trusted couriers and provides tools to upload customs documentation electronically. You can upload customs documents directly through the “My Shipments” page on ShipNerd by doing the following:

• Go to “My Shipments” and find your export shipment
• Click on the “i” in the actions column on the right side of the page to expand order info
• In the bottom left of the expanded window click on “Upload Documents”

Following FDA shipping regulations doesn’t have to be complicated. With accurate paperwork and a reliable partner like ShipNerd, your FDA-regulated shipments can move across borders smoothly and efficiently.