How FDA Registration Works

How Does FDA Registration Work?

Before walking through how FDA registration is carried out, a note on why it is required: under the Bioterrorism Act, all US and foreign food establishments that manufacture, process, pack, or hold food for animal or human consumption intended for sale in the United States must register with the FDA. Products imported from firms that have not registered are held at the US port of entry and will not be allowed into the country.

The information needed for registration includes: the name, address, and phone number of the firm (and parent firm, if any); the name, address, and phone number of the owner or authorised representative; all trade names used by the firm; the product categories handled at the facility; the declaration by the filer that the information submitted is true and accurate; and, for foreign firms, the name, address, and phone number of the US agent plus a contact phone number for the US agent or another person to be reached in emergencies. Additional information can be provided on an optional basis.

The foods covered by the Act include: food, infant food, beverages, fruits and vegetables, dairy products and eggs, fish and seafood, unprocessed agricultural products used as food, bakery products, canned and frozen foods, confectionery (including chewing gum), live food animals, pet food, animal feed, and related products.

The following operators are outside the registration scope: private residences where food is processed, manufactured, packed, or held; entities that distribute drinking water without bottling; farms; vehicles transporting food; retail food establishments (such as supermarkets); restaurants; non-profit food establishments; fishing vessels; and poultry, meat, and egg establishments inspected by the US Department of Agriculture.

When food manufactured, packed, or held by one foreign firm is imported into the US through another foreign firm, the first foreign firm's registration obligation depends on the second firm's role. If the second firm performs only minor activities (such as label application), both firms must register.

Prior Notice of Food Imports to the FDA

Under the Bioterrorism Act, starting 12 December 2003 food products destined for import into the US must be electronically notified to the FDA in advance by the customs broker, importer, US agent, or any party with information about the products, and a confirmation number must be obtained from the FDA. Based on that notification, the FDA decides whether to inspect the incoming shipment.

Products for which prior notice has not been filed, or has been filed incompletely, will not be allowed entry into the US and will be held at the port or in a secure storage facility. Prior notice can be filed through the Automated Broker Interface or the Automated Commercial System using the FDA prior-notice format.

The prior notice must include: the filer's name, phone, email, fax, firm name, and address; if the submitter is different from the person supplying the information, the submitter's name, phone, email, fax, firm name, and address; the name and quantity of the products; the manufacturer's identification details; where applicable, the identification details of the producer and the country of origin; the shipper's details; the country from which the products are shipped; the estimated arrival date and place; the importer's details; the carrier that will handle transport after entry; the mode of transport; and the shipment coordination details. If any of this information changes after the notice is filed, a new notice must be filed.

The following are outside the scope of the prior-notice obligation: food products brought by travellers for personal consumption (not commercial purposes); food products that do not leave the US port of arrival before being exported to another country; meat, poultry, and egg products regulated by the US Department of Agriculture; and food products produced at home by someone outside the US and sent as a gift to a US resident for personal consumption.