Import Prior Notice to FDA – Mandatory for Every Shipment to the U.S.
Under 21 CFR Part 1, Subpart I, the FDA requires Prior Notice for all dietary supplement and food product shipments entering the United States. This alert must be submitted before the shipment arrives at the port of entry. Without it, your products risk being refused, detained, or destroyed by U.S. authorities.
Who Needs It?
- • Foreign Manufacturers & Exporters shipping supplements to the U.S.
• U.S. Importers, Brokers & Distributors handling compliance
• Freight Forwarders managing international customs
• eCommerce & Amazon FBA Sellers importing finished goods
Why It’s Required:
- • Mandatory FDA requirement under the Bioterrorism Act
• Ensures FDA is notified about incoming food/supplement shipments
• Required per shipment—not per product or company
• Essential for smooth customs clearance and avoiding costly delays
What’s Included:
- • Filing of Prior Notice via FDA’s Prior Notice System Interface (PNSI)
• Product Category Classification & Harmonization Support
• Confirmation Document for Customs & Freight Brokers
• Emergency Contact & Facility Verification
• Filing Record Provided for Audit & Tracking
• Support for Recurring Shipments (Template Setup Available)
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| Import Prior Notice Filing (Per Shipment) | $350 | $175 |
- Support360 Members enjoy 50% OFF import compliance services—including Prior Notice, FDA Registration, and FSVP Agent support.
What Happens If You Don’t File?
- • Refused entry at the port by FDA and CBP
• Product detentions, fines, or disposal
• Missed Amazon FBA check-in dates and lost sales
• Increased inspection risk on future imports
