FDA Prior Notice Web Entry: How to Submit Your Import Information Online

The FDA Prior Notice Web Entry is an online system that allows importers to submit information about their shipments before they arrive in the United States. This system was implemented as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which requires the FDA to receive prior notice of imported food, including animal feed, at least four hours before it arrives in the U.S. This system is designed to help the FDA identify and prevent potentially harmful food from entering the country, and to ensure that imported food meets U.S. safety standards.

The FDA Prior Notice Web Entry system is user-friendly and accessible to anyone with an internet connection. Importers can submit their prior notice information online, and the system will provide them with a confirmation number that they can use to track their shipment. The system also allows importers to make changes to their prior notice information if necessary. In addition, the FDA Prior Notice Web Entry system is available 24/7, which means that importers can submit their prior notice information at any time, even outside of regular business hours.

Overall, the FDA Prior Notice Web Entry system is an important tool for ensuring the safety of imported food in the United States. By requiring importers to submit prior notice information, the FDA can identify and prevent potentially harmful food from entering the country, and can ensure that imported food meets U.S. safety standards. The system is user-friendly and accessible, which makes it easy for importers to comply with the prior notice requirements.

Understanding FDA Prior Notice

Legal Framework and Requirements

FDA Prior Notice is a requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This law mandates that any article of food that is imported or offered for import into the United States must be accompanied by prior notice to the FDA. This requirement is designed to enhance the safety and security of the US food supply by enabling the FDA to identify and intercept potentially harmful foods before they enter the country.

The FDA Prior Notice requirement applies to all articles of food, including dietary supplements and animal feed. The notice must be submitted electronically to the FDA at least 24 hours before the food arrives at the port of entry. Failure to comply with this requirement may result in the food being refused entry into the United States.

Food Categories and Entities Subject to Notice

The FDA Prior Notice requirement applies to all articles of food, regardless of the food category or the entity that is importing the food. This includes foods that are intended for human consumption, as well as foods that are intended for animal consumption.

Entities that are subject to the FDA Prior Notice requirement include importers, brokers, and carriers. These entities are responsible for ensuring that the required notice is submitted to the FDA prior to the food arriving at the port of entry.

In conclusion, understanding the FDA Prior Notice requirement is essential for any entity that is involved in importing food into the United States. By complying with this requirement, importers can help to ensure the safety and security of the US food supply, while also avoiding potential penalties for non-compliance.

Submitting Prior Notice

Web Entry Process

Submitting prior notice to the FDA is a crucial step in ensuring the safety and security of imported food products. The web entry process is a simple and efficient way to submit prior notice to the FDA. The process involves creating an account on the FDA’s Prior Notice System Interface (PNSI) website and submitting the required information.

To submit prior notice, the user must first log in to their PNSI account. Once logged in, the user can create a new prior notice submission by entering the required information, including the product name, manufacturer, country of origin, and intended port of arrival. The user can also attach any relevant documents, such as invoices or certificates of analysis.

After submitting the prior notice, the user will receive a confirmation number and a status update on the submission. The FDA will review the prior notice and notify the user if any additional information is required.

Compliance and Enforcement

It is important to note that failure to submit prior notice or submitting incomplete or inaccurate information can result in enforcement action by the FDA. The FDA has the authority to refuse admission of the imported product, issue warning letters, and even initiate legal action against the importer.

To comply with FDA regulations, it is crucial to ensure that all prior notice submissions are accurate and complete. The FDA provides guidance and resources to help importers understand and comply with the regulations. It is recommended that importers review the FDA’s guidance documents and seek the advice of experts in the field to ensure compliance with FDA regulations.

In summary, the web entry process for submitting prior notice to the FDA is a simple and efficient way to ensure the safety and security of imported food products. However, it is important to comply with FDA regulations and submit accurate and complete information to avoid enforcement action.