US Food and Drug Administration (FDA) Registration: What You Need to Know

According to the Food and Drug Administration (FDA), 20 percent of U.S. imports are food items. The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 or bio-terrorism Act aims to protect the United States against bio-terrorist threats (including food coming from abroad) to its food supply.

 

Among the agencies that determine whether food products can be admitted into the U.S. is the FDA. The U.S. Customs and Border Protection (CBP) enforces the requirements set by the FDA and other regulatory agencies. Under the bio-terrorism Act, CBP can return or abandon all shipments that do not comply with requirements and administer penalties for noncompliance.

 

What does this mean for importers and foreign food manufacturers and distributors?  Foreign facilities that manufacture, process or pack food for human or animal consumption in the U.S. must register with FDA, while U.S. importers, purchasers and their agents must submit Prior Notice (PN) to the FDA before importing food.

 

US Food and Drug Administration (FDA) Registration: What You Need to Know

Prior Notice is a pre-arrival notification sent by traders to FDA about incoming food shipments. Prior notice must be submitted at least four hours before the shipment arrives at the port but not more than five days before arrival. The Prior Notice generally includes information about the product, quantity, packaging, manufacturer, shipper, owner, and consignee.

 

Additional information may be required for certain entry types. If you are importing food for resale or commercial purposes, you must understand the details of handling different food items. The import requirements depend on the type of food, the country of origin, and whether the food is restricted or under a quota. The types of commodities the FDA considers as food and require Prior Notice include everything from infant formula to pet food. Items that are exempt from Prior Notice requirements are:

 

·         Meat, poultry and egg products that are under exclusive jurisdiction of the U.S. Department of Agriculture (USDA) and comply with the USDA regulations.

·         Homemade food and all personal food shipments sent person to person for non-commercial use.

·         Food samples for non-consumption valued below $200, including food samples destined for testing labs or manufacturers, but not to retailers or individuals.

 

Filing an entry with FDA and CBP can be very time-consuming, and many importers prefer to work with a customs broker or third party provider to save time and facilitate processing of high-volume shipments.

 

US FDA Registration General Import Requirements

 

All food and beverage products that are imported for commercial purposes require the importer to file a Prior Notice with FDA. Animal origin products such as meat, poultry, eggs, and milk may also require health certificates, permits, and other certifications from the country of origin. These requirements usually do not apply to food for personal use sent by an individual or accompanying an inbound traveler. If you are unsure of the requirements for a particular food article, contact the FDA or consult with your broker/CBP Import Specialist at the port where the goods will arrive.

 

Foreign manufacturers and distributors of food products must be registered with FDA before the goods can enter the U.S. CBP will hold food shipments if there is no proof that the importer has filed a Prior Notice with FDA. Entry documents and the PN confirmation number must be submitted to CBP, with the barcoded PN confirmation number to be included in the air waybill, bill of lading, or other shipping documents. FDA may collect a sample of the food item once it arrives at the U.S. port, or FDA may tell CBP to release the shipment. If the sample is found to violate FDA regulations, the importer will receive a notification from FDA.

 

How to Register: Getting an FDA Registration Number

 

All facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with FDA. Required data for registration include the name, address and phone number of the facility, parent company (if applicable), and the owner operator or person in charge, all trade names of the facility, applicable categories of food products, and certification that the information submitted is true and accurate and the person is authorized to submit the registration. Foreign or non-U.S. facilities must designate a U.S. agent who lives or has a place of business in the U.S. The agent must be physically present in the U.S. to register.

 

In addition to the above requirements, facilities must also submit an assurance that FDA will be permitted to inspect the facility. Food facilities must renew registrations every other year. If there are changes to the information in the submitted application, the update must be submitted within 60 days of the change.

 

To register your company facilities with the FDA, go directly to the FDA website. After following the steps, domestic registrants will see a message that registration was submitted successfully. Save the following important data: FDA Registration Number or the number assigned by FDA to the facility, the Personal Identification Number (PIN) for the registration, and the registration expiration date. The FDA number is required for all your transactions with FDA, including filing Prior Notice for shipments, while the PIN allows you to access the registration information online.

 

For non-U.S. facilities, the U.S. agent must first respond to the confirmation request before the FDA can issue the registration number and PIN. Once registered, you can work with a third-party company to file Prior Notice with the FDA for your imports.

 

FDA Prior Notice and Prior Notice System Interface (FDA PNSI)

 

Since December 2013, Prior Notice has been required by FDA for all imported food for human and animal consumption. You can submit Prior Notice for food shipments:

 

1) Through the CBP Automated Broker Interface/Automated Commercial System (ABI/ACS) that is connected with FDA

2) Directly through the Prior Notice System Interface (PNSI) on the FDA website, or

3) Using an FDA Prior Notice solution provided by a third-party vendor like CrimsonLogic’s Global eTrade Services (GeTS)

 

The PNSI is for individuals or companies that choose not to file through ABI. It is a web-based portal that allows traders to submit notifications, registrations and listings to FDA. The PNSI can be used as an alternative filing portal to the ABI/ACS interface.

However, the PNSI is not designed for high-volume users and they may find that a dedicated filing solution is better suited to their needs.

 

Filing Prior Notice through FDA PNSI

 

Filing Prior Notice through PNSI is straightforward. The carrier or customs broker usually submits the Prior Notice to FDA, but anyone who has the food shipment information and requirements can do so using PNSI or third-party software.  

 

 

GeTS FDA PNSI Solution

 

Global eTrade Services (GeTS) is a CBP-approved third party provider offering best-in-class software-as-a-service for the trading community. GeTS aims to accelerate cross border trade through its comprehensive suite of services, which includes FDA PNSI. GeTS’ FDA PNSI solution is a web-based application that allows traders—individuals, manufacturers, exporters, brokers, importers, freight forwarders and agents—to facilitate the creation and filing of Prior Notice with the FDA.

 

The GeTS FDA PNSI solution features an intuitive interface that allows users to upload shipment data in CSV or XML format via the GeTS portal. Clients can also integrate their existing Enterprise Resource Planning (ERP) systems with GeTS FDA PNSI to save time. Users can track FDA messages directly from their smartphones using the GeTS mobile app or get shipping alerts via email or SMS.

 

Unlike direct filing on the FDA website, GeTS FDA PNSI features 24/7 customer support, a secure corporate account, multiple plans and connectivity options, report generation, and advanced integration options. You can choose a web subscription for convenient Prior Notice filing on the go and anywhere there is an Internet connection; a fax subscription for processing of requests via fax or email; or, integration with your in-house software systems. Visit our website to learn more or to register for a 30-day free trial. You may also send us a message through the online form on the Contact Us page.

 

Related Pages:

Prior Notice Requirement

ACE Highway

FDA Prior Notice System Interface (PNSI) Service