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

ShipNerd now makes it easier to ship FDA-regulated products internationally by allowing you to enter FDA information directly while creating your shipment. This means you no longer need to submit separate FDA paperwork outside of ShipNerd for eligible shipments.

When creating an export shipment for FDA-regulated goods, you’ll now see an FDA Information section during the shipment creation process. This allows you to provide all required FDA details directly in ShipNerd before generating your label.

This feature helps simplify compliance for products such as:

• Certain medical or health-related products
• Food and beverages
• Chocolate and candy products
• Dietary supplements
• Cosmetics

How It Works

During shipment creation, you’ll be prompted to complete FDA-related fields for the item being exported.

The form includes fields such as:

• Manufacturer Name
• Manufacturer Address
• Manufacturer City/State/Country
• Manufacturer Postal Code
• Intended Use
• Prior Notice Confirmation Number
• FSVP Consent with a DUNS Number for the Importer

Once completed, this information is submitted electronically as part of the export documentation workflow.

Accurate Information Matters

Providing complete and accurate FDA information is important to help ensure your shipment clears customs smoothly and avoids unnecessary delays.

Incorrect or missing information may result in:

• Customs clearance delays
• FDA holds or inspections
• Shipment returns
• Additional documentation requests

To help prevent issues, make sure all manufacturer and product details are entered exactly as required before submitting your shipment.

Nerd Tip: You must use the full 10 digit HS-code to return accurate rates!

Example

Important Notes

• ShipNerd does not validate FDA registration details entered by the shipper, so it’s important to verify the information before submission.
• FDA information requirements depend on the product type and destination country.
• Some fields may be optional depending on the shipment.
• Prior Notice Confirmation Numbers should be obtained before shipment if required by the FDA.