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Table of Contents:
Streamline Your FDA Compliance: Entry and Prior Notice Filing
Required Data Elements
Prior Notice Filing
How GeTS Can Help Streamline Your FDI Compliance
FDA Prior Notice (PN) Features and Benefits
U.S. Customs and Border Protection (CBP) refers all imports regulated by the Food and Drug Administration (FDA) to the agency for review. In general, imports are subject to the same standards as domestic products. Most importers hire a licensed customs broker to report FDA-regulated shipments to CBP and to process other required documentation. Read on to learn more about FDA Prior Notice (PN) and how to streamline your FDA compliance.
The FDA regulates many products: food, animal feed, cosmetics, tobacco products, radiation emitting electronics, biological products and medical products (drugs and devices). Each product is subject to specific regulations and requirements. Until FDA has determined admissibility, imports are not allowed to enter the market.
FDA-regulated shipments can be for personal or commercial use. Commercial imports are those brought into the U.S. for sale or distribution. Commercial imports can be declared to CBP and FDA under different entry types, including formal, informal, import for export, consumption and warehouse.
While most entries are approved for entry, certain imports may be denied if they are found by the FDA to be adulterated, misbranded or forbidden for sale. Adulterated products are considered contaminated, unsafe, unapproved and do not meet standards, while misbranded products are those with labels containing false or misleading information. Forbidden products are products that cannot be sold in the U.S. If refused entry, the shipment must be destroyed or exported from the U.S. within 90 days.
Imports may also be held if they are deemed high risk. These include entry submissions with incomplete or inaccurate information. The FDA uses various methods to determine whether a shipment can enter the U.S. or not. The agency reviews the importer’s compliance history and problems with a certain product, and they check the registration database to verify whether a declared drug/medical device manufacturer complies with facility registration requirements.
Entries filed by the importer or broker are classified by their Harmonized Tariff Schedule (HTS) code indicating whether or not the they should be forwarded to the FDA. Self-filing importers of record (IOR) or their authorized agents (licensed customs broker) are responsible for filing entries (shipment data) and entry summaries (accounting documentation) for FDA-regulated goods.
FDA-regulated goods usually require additional or specific data. For example, entries for food imports requiring Prior Notice must include the country of production or place of growth, country of shipment, names and addresses of the Prior Notice filer, ultimate consignee, owner and grower/consolidator, container number, quantity, packaging, port of arrival, and affirmations of compliance (if applicable).
Since June 2016, the following data are also required to be submitted when clearing food shipments: product code, device listing number (LST), intended use code, brand name, active Ingredient name, manufacturer registration number and 510 (K) number.
An entry number is used to track each FDA-regulated shipment. The entry number starts with the 3-digit filer code of the customs broker followed by an additional 8 digits. The filer code consists of letters and/or numbers. FDA will evaluate the shipment based on the submitted information as well as additional documents like the invoice or bill of lading.
Food and feed products must be accompanied by a Prior Notice. The Prior Notice is an electronic notification transmitted to the FDA before the shipment arrives in the U.S. Prior notification of food and feed imports improves risk assessment and helps CBP intercept high-risk and unsafe products. The FDA must receive and validate the Prior Notice within the following time frames:
Highway: 2 hours before arrival
Rail: 4 hours before arrival
Air: 4 hours before arrival
Ocean: 8 hours before arrival
Exemptions to the Prior Notice rule include meat, poultry and egg products regulated by the U.S. Department of Agriculture (USDA), homemade food and food imports for personal use, food samples for non-consumption valued below $200, and imported food for immediate export (without leaving the port of arrival).
The Prior Notice must contain the following data elements:
Additional data may be required for certain products and entry types. The broker or importer must submit the PN confirmation number to CBP, and the barcoded number must appear on the bill of lading and other shipping documents.
Filing can be done through the Automated Broker Interface (ABI) in the Automated Commercial Environment (ACE) or the Prior Notice System Interface (PNSI) on the FDA website. The PNSI is available to filers who are unable or choose not to file through the ABI. Filers often use the PNSI for international mail shipments, in-bond entries and FTZ entries that do not require a full CBP entry at the time of filing the Prior Notice. The PNSI is also useful as a backup in case ABI or ACE is down for maintenance.
PNSI filing is free of charge, but it is not intended for high-volume filing. Information must be entered manually, and this can be very time consuming if you are a frequent importer or run a large business. This is why most importers hire a customs broker to file required documentation to CBP and the FDA on their behalf.
Filers, whether importers or brokers, use software to connect directly and transmit data electronically to CBP. Software can be developed in-house or purchased from a third party. The latter is popular because it is more affordable and eliminates costs associated with development, training and maintenance.
The U.S. Food and Drug Administration (FDA) requires importers or their brokers to provide additional information to U.S. Customs and Border Protection (CBP) to clear food shipments. In order to avoid delays in shipment clearance and delivery, you and your suppliers and affiliates outside the United States will need to take important steps to comply.
Many companies today outsource this work to their logistics providers or third parties for a fee. But did you know you can self-file Prior Notice directly to FDA for as low as $1.00? Global eTrade Services (GeTS) is a leading provider of Customs Compliance solutions that include FDA-PN software.
GeTS’ FDA-PN solution is a web-based application that allow users to submit prior notice to FDA on user-friendly interface with no assistance. Users are able to file multiple PNs and receive confirmation from the FDA within minutes. Shipments can be tracked in real-time via email or mobile app.
Integration options are available to pull data from ERP or in-house systems to enable seamless workflows. Food exporters, packagers and other shippers have saved costs and time sending prior notice through GeTS platform to FDA.
To learn more, visit our FDA compliance page or contact us today.
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