In  Factors That Affect Your Shipments to the US – Part 1, we discussed PREDICT, the system the U.S. Food and Drug Administration (FDA) uses to forecast which shipments to examine or sample at the U.S. port of entry. We considered how inherent product risk and a history with compliance issues can raise a company’s PREDICT score, increasing the likelihood that their shipments may be stopped at the U.S. port.

Here, we explore factors that can affect your PREDICT score and steps you can take to help your shipments enter the U.S. more smoothly.

Registration and U.S. Agent

Typically, the first step that exporters take when shipping to the U.S. is registering their products with FDA. The Bioterrorism Act of 2002 required facilities that manufacture, process, pack, or store food for consumption in the U.S. (including beverages and dietary supplements) to register their facilities with FDA.

In addition, foreign facilities must designate a U.S. Agent for FDA communications. The U.S. Agent must be present in the U.S. and available 24 hours a day to discuss regulatory matters with FDA on the facility’s behalf. FDA may send important correspondence to the U.S. Agent.

The Food Safety Modernization Act (FSMA) requires food facilities to renew their FDA registration every two years on even-numbered years. Facilities must renew their registration during the renewal period regardless of when they initially registered. FDA will cancel a facility’s registration if it does not renew by the deadline. Facilities often do not know their registration is canceled until a shipment is detained at the U.S. port of entry. If you are not sure whether your facility has a valid FDA registration you should verify your registration before you ship your products to the U.S.

Food facilities are also required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing an FDA registration. Data Universal Numbering System (DUNS) numbers are currently the only UFI recognized by FDA.

Registrar Corp’s Food Facility and U.S. Agent Services include assistance with obtaining or managing your facility’s UFI.

Prior Notice

Prior Notice is notification to FDA that a shipment is coming to the U.S. You must file a Prior Notice for every food, beverage, and dietary supplement shipping to the U.S., including samples. If you do not file a Prior Notice, your shipment will very likely be detained. Prior Notice includes information about the shipment and the facility, including details about the shipper, the manufacturer, and the purchaser or consignee’s information, as well as identification of the products contained in the shipment. Prior notice can be filed by the importer, exporter, or by a third party that has knowledge of the shipment.

You can determine when to file Prior Notice by identifying your shipment’s mode of transport. Prior Notice must be submitted and confirmed by FDA no less than:

• 2 hours prior to arrival for shipments arriving by road
• 4 hours prior to arrival for shipments arriving by rail
• 4 hours prior to arrival for shipments arriving by air
• 8 hours prior to arrival for shipments arriving by water

When shipping to the U.S. via international mail or express couriers, the Prior Notice should be submitted before the package is shipped. Prior Notice should not be submitted more than 15 days before the shipment will arrive.

Labeling

FDA defines “labeling” as “all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such an article.” This may include packaging, instructions, product inserts, websites, and other promotional materials. It is important to make sure that your labeling is compliant with labeling regulations for your product. You must ensure your product is not making claims that violate FDA’s regulations. Labeling errors are one of the leading causes of FDA detentions, accounting for approximately 22% of all detentions in the U.S.

You can reduce the likelihood that your shipments will be stopped at the port of entry if you confirm that your shipments and the products they contain are in compliance with all applicable FDA regulations.