FDA Prior Notice Requirements and Automation
The global food industry is subject to strict regulations designed to ensure the safety of food for human and animal consumption.
In the United States, the Food and Drug Administration (FDA) plays a central role in this mission.
One of the FDA’s key requirements is to submit prior notices for food and drink shipments shipped into the United States.
This requirement provides the FDA with the time and information necessary to evaluate and potentially inspect food before it arrives, thereby strengthening the security of the food supply chain.
Compliance with prior notice requirements is crucial for companies exporting food to the United States. Failure to comply with these rules can result in delays, denial of entry, or even penalties.
Given the complexity and challenges associated with the prior notice requirement, automating the prior notice process with the PriorNotify app has become a necessity for businesses to ensure efficiency, accuracy, and compliance.
Understanding FDA Prior Notice Requirements
Prior notice is a legal requirement that shippers or their agents must notify the FDA before a food or drink shipment arrives in the United States.
This notice must be sent electronically through the Prior Notice System Interface (or PNSI) of the FDA.
The information required in the prior notice must be provided for each food or drink product in each shipment:
- The identity of the sender and the recipient for each shipment.
- The identity of the carrier for each shipment.
- The country of origin of each of the food or drink products in each shipment.
- A detailed description of the food or drink products, including the trade names, identification codes, quantity, and packaging.
- The date and time the shipment is expected to arrive at the U.S. port.
The prior notices must be submitted within specific timeframes prior to the arrival of the shipment. These time limits vary depending on the mode of transport.
In general, for most international shipping, the prior notice must be submitted before or at the time of shipping from the foreign country.
Specifically, if the shipment will arrive in the United States by airplane or train, the prior notice must be submitted no later than 4 hours before arrival at the American port. If the shipment will arrive in the United States by sea, the prior notice must be submitted no later than 8 hours before arrival at the American port. If the shipment will arrive in the United States by truck (by road), the prior notice must be submitted no later than 2 hours before arrival at the port.
It is important to note that certain foods are exempt from the advance notification requirement, including non-business personal gifts, low-value commercial samples, and food transported with a traveler and intended for a travelers’ personal consumption. However, it’s the sender’s responsibility to determine whether their shipment is truly exempt.
Failure to comply with the Prior Notice requirements can have significant consequences. The FDA may detain, refuse entry, or order the destruction of non-compliant foods. Civil and criminal penalties may also be imposed.
The Challenges of Manually Submitting Prior Notices
For companies exporting food products to the United States, manually entering the data and submitting the information required for Prior Notices can be time-consuming, costly, and prone to human error.
Each prior notice can take 7 to 10 minutes or more to submit. This manual approach is costly and unpleasant. With higher numbers of shipments, repeatedly entering the required information for each submission increases the risk of transcription errors.
Moreover, the information needed for each prior notice may be stored in different systems (order management, logistics, and similar), making data collection and consolidation difficult.
Faced with these challenges, automating the pre-notification process is a completely logical and effective solution.
Automation of the Prior Notice Process
Automating the prior notification process involves using integrated software and systems, such as PriorNotify, to electronically collect, validate, and submit the required information to the FDA.
All this can be achieved easily and economically with PriorNotify.
This approach offers many advantages. For example, automation minimizes manual data entry, reducing the risk of human error and non-compliance. Automation also streamlines the Prior Notice submission process, allowing businesses to comply with the requirements more quickly and free up human resources for other tasks.
Moreover, solutions like PriorNotify integrate easily with existing order management systems, as well as websites and eCommerce stores like Shopify, PrestaShop, WiX, WordPress, Magento, and others, to automatically assemble the necessary information, eliminating the need for multiple manual entries.
Conclusion
Compliance with FDA prior notifice requirements is a fundamental obligation for companies exporting food to the United States.
Automating this process offers significant benefits in terms of error reduction, time savings, improved compliance, and data integration.
By adopting the right technologies with automation, businesses can streamline their operations, minimize risks, and ensure smooth trade with the United States.
Submitting the required prior notices automatically with PriorNotify is not only a matter of operational efficiency, but also a proactive approach to ensuring regulatory compliance and protecting operations and future profits in the U.S. market.
