Customs Clearances, FDA Prior Notice Web Entry Explained for Efficient Import Compliance.docx

Customs clearance and FDA Prior Notice Web Entry are critical steps in importing regulated food products into the United States. They involve several procedural and regulatory requirements that ensure shipments comply with federal safety standards and can be processed efficiently.

1. Customs Clearances, FDA Prior Notice
Web Entry Explained for Efficient Import
Compliance
Customs Clearances is a critical step for any shipment entering the United States,
particularly when food and beverage products are involved. To meet regulatory
requirements, importers must submit an FDA Prior Notice through a secure web entry
system before the shipment arrives. This prior notice alerts the FDA to incoming products
and must be submitted within strict timelines to avoid delays, penalties, or refusal of entry.
The FDA Prior Notice Web Entry system offers a streamlined way for importers and customs
brokers to submit detailed information about the shipment, ensuring compliance with U.S.
food safety laws. It is essential for preventing bottlenecks at the border by allowing the FDA
to review and authorize shipments in advance. Proper use of this system supports smooth
customs processing and faster release of goods.
Importers who understand the importance of accurate and timely submissions gain a
significant advantage in avoiding costly delays. Navigating the complexities of FDA
regulations and customs clearance requires attention to detail and familiarity with the
required documentation. This introduction sets the foundation for a deeper look into how
the FDA Prior Notice and customs clearance intertwine in the import process.
Understanding Customs Clearances and FDA Prior Notice Web Entry
Customs clearance and FDA Prior Notice Web Entry are critical steps in importing regulated
food products into the United States. They involve several procedural and regulatory
requirements that ensure shipments comply with federal safety standards and can be
processed efficiently.
What Is Customs Clearance
Customs clearance is the process where shipments are reviewed and authorized to enter a
country. For the U.S., this involves U.S. Customs and Border Protection (CBP) verifying
documentation, duties, and compliance with laws.
During clearance, shipments undergo inspection to confirm they meet import regulations.
This includes verification of certificates, valuation, and compliance with safety standards.
The process can involve a customs broker who files entries and submits necessary
paperwork on behalf of importers. Successful customs clearance allows the release of goods
for distribution or sale within the U.S.
FDA Prior Notice Regulatory Requirements

2. The FDA requires importers to submit a Prior Notice before food products arrive at a U.S.
port. This advance notification allows the FDA to review shipments for potential safety risks.
Importers must provide detailed information, including product description, quantity, origin,
and shipment arrival details. The submission is made through the FDA Prior Notice Web
Entry system.
Prior Notice must be filed before arrival: from a few hours to up to five days depending on
shipment mode. Failure to submit or incomplete submissions can lead to shipment delays,
refusals, or penalties.
This requirement applies under Title 21 CFR Part 1, Subpart I, which aims to protect public
health by allowing timely FDA screening of imported food.
Types of Shipments Requiring Prior Notice
Prior Notice is mandatory for all food products for humans or animals that are imported or
offered for import into the U.S.
This includes:
Packaged foods and beverages
Raw agricultural products
Ingredients used in food manufacturing
Dietary supplements and pet food
Shipments that are exempt include personal food imports for individual consumption below
certain quantities or certain non-food items.
Providing accurate and timely Prior Notice ensures shipments undergo FDA and CBP
screening without unnecessary delays, facilitating smooth customs clearance.
Step-by-Step Guide to Filing FDA Prior Notice Online
Filing an FDA Prior Notice requires precise steps to ensure compliance with U.S. import
regulations. The process begins with account registration, moves through completing
detailed web entry forms, and ends with submitting the notice for official confirmation.
Avoiding common errors is essential to prevent delays or rejections.
Registering for the FDA Account
Before submitting a Prior Notice, the importer or their agent must register for an FDA
account through the FDA Prior Notice System Interface (PNSI). This involves providing basic
company information such as the name, address, and contact details.
After registration, users receive login credentials enabling access to the web portal. It is
crucial to keep these credentials secure, as they are required for all future submissions.

3. Registration typically takes a few days to process, so it should be done well before the
import date.
Completing the Prior Notice Web Entry Form
The web entry form gathers detailed information about the shipment. This includes
manufacturer or grower details, shipper information, ultimate consignee, and product
description. The country of origin and shipment location must be accurately selected from
drop-down menus in the portal.
All relevant fields marked as mandatory must be completed; missing information can delay
processing. Users should also specify the intended port of arrival and anticipated arrival
date. Quality control and accuracy at this stage minimize rejection by the FDA.
Submission Process and Confirmation
Once the form is completed, users must review all data carefully before final submission.
Simply saving the entry does not submit the Prior Notice. Users must explicitly submit the
notice for FDA review.
Upon submission, the FDA issues a confirmation number and barcode. This number must
accompany the shipment documentation and be reported on the commercial invoice. The
confirmation number verifies that the shipment complies with FDA regulations and is crucial
for customs clearance.
Common Mistakes to Avoid
Incomplete or incorrect information is the most frequent cause of Prior Notice delays.
Common errors include leaving mandatory fields blank, entering wrong manufacturer
location, or misreporting shipment dates.
Another mistake is failing to submit the notice after saving it, which means the FDA will not
have it on record. Using outdated account credentials or not registering before the import
can also cause issues.
Double-checking all entries and submitting well in advance helps avoid these problems.