Importing food and FDA-regulated products into the United States requires compliance with specific rules, including the submission of a Prior Notice to the U.S. Food and Drug Administration (FDA). This notice provides the FDA with critical information about the shipment before it arrives, helping ensure safety and proper entry processing.Section 321 of the Tariff Act allows certain low-value shipments—those valued at $800 or less—to enter the U.S. duty-free under the “de minimis” provision. However, even shipments qualifying under Section 321 must comply with the FDA’s Prior Notice requirement when they involve food or FDA-regulated items.

Understanding both the FDA Prior Notice and Section 321 customs entry process is essential for importers to avoid delays, penalties, or shipment refusals. This article breaks down these requirements clearly to help navigate the complex regulations involved.

Understanding US FDA Prior Notice and Section 321 Customs Entry

The US FDA Prior Notice process ensures the agency receives advance information about imported food shipments. Section 321 customs entry allows eligible items valued at $800 or less to enter the US duty-free. Both systems involve specific requirements that importers must follow to ensure compliance and efficient clearance.

Overview of US FDA Prior Notice

FDA Prior Notice requires electronic submission to the FDA before food or beverage shipments arrive in the US. This helps the FDA evaluate potential health risks and prevent illegal imports.All food for humans or animals must have Prior Notice filed, regardless of shipment value or size. The notification includes details like the shipment’s origin, contents, and arrival time.Submitters must use the FDA Prior Notice Web Portal and provide the prior notice number to the carrier. Failure to provide Prior Notice can lead to shipment delays or refusal.

Section 321 Customs Entry Explained

Section 321, under 19 USC 1321, allows qualifying shipments valued at $800 or less to be imported duty- and tax-free. It is often called the de minimis entry.Section 321 expedites clearance by simplifying entry procedures and reducing costs for small-value shipments. It covers most product types, but some categories have additional FDA-specific requirements.

The rule limits exemptions to one shipment per person per day with a maximum $800 retail value. Importers using Section 321 must still comply with all applicable FDA requirements.

Key Compliance Requirements

For food shipments under Section 321, submitters must include the correct Harmonized System (HS) tariff number on invoices. The FDA Prior Notice must also be filed electronically in advance.The prior notice number and documents must be provided to carriers to support entry under Section 321. Importers should verify all information accurately to avoid Customs or FDA issues.Other requirements include registration with the FDA for certain businesses and adherence to labeling and safety standards. Importers can contact the FDA’s Import Operations division for assistance.

Differences Between Section 321 and Other Entry Types

Section 321 differs from formal or informal customs entries mainly in its value limit and simplified process. Formal entries are required for shipments above $800 or those needing detailed inspection.While Section 321 offers duty and tax exemptions, formal entries may involve fees, duties, and more documentation. FDA Prior Notice remains mandatory for all food imports regardless of the entry type.Certain low-value shipments may qualify for manual release without prior FDA notification, but this is limited to specific circumstances under FDA guidance. Importers must understand these distinctions to choose the correct entry process.

Best Practices for Compliance and Import Success

Ensuring smooth importation requires precise submission of prior notice, understanding Section 321 shipment rules, thorough documentation, and staying current with regulatory changes. Attention to detail in these areas reduces delays and avoids penalties.

Filing Accurate Prior Notice

Importers must submit electronic prior notice to the FDA before food shipments arrive in the U.S. Accuracy in product description, shipment quantity, arrival date, and manufacturer details is essential. Inaccurate or incomplete information can result in shipment holds or refusals.The prior notice must be complete and submitted within the required timeframe, typically no more than 15 calendar days and no less than 2 hours before arrival. Importers should verify the details against purchase orders and bills of lading to avoid discrepancies.Using reliable software or FDA-approved platforms for submission minimizes errors. Continuous review of FDA notifications post-submission ensures any requests for correction are promptly addressed.

Avoiding Common Mistakes in Section 321 Shipments

Section 321 allows certain low-value food shipments to be exempt from duties and formal entry but still requires prior notice to the FDA. Misunderstanding this can lead to improper filing or overlooked requirements.Common mistakes include failing to submit prior notice despite the low value or small quantity, misclassifying shipments, and ignoring FDA protocols on de minimis shipments. Even shipments valued below the threshold must be reported.Importers should confirm eligibility for Section 321 by reviewing FDA guidance and consulting with customs brokers. Clear communication with logistics providers about prior notice duties prevents compliance gaps.

Documentation and Recordkeeping

Maintaining thorough records related to FDA prior notice filings and Section 321 entries is critical for compliance verification and audits. This includes electronic confirmations, shipment invoices, customs paperwork, and communication logs.Records should be stored securely and be easily accessible for the FDA or Customs and Border Protection (CBP) reviews for at least two years. Proper documentation supports dispute resolution and can demonstrate regulatory adherence. Establishing a consistent file management system and training staff on record requirements enhances overall import reliability and facilitates quick response to inspection requests.

Maintaining Regulatory Updates

FDA regulations and guidance on prior notice and Section 321 shipments can change. Staying informed prevents non-compliance and unexpected shipment delays.Importers should subscribe to FDA newsletters, monitor updates from Customs and Border Protection, and regularly consult official FDA portals for revised rules or clarifications.Periodic training sessions and compliance audits ensure internal processes align with current standards. Engaging with industry groups or consultants can provide additional insights into regulatory trends.