- Prepare. Learn about the rules that surround the import of food products in the USA. Some apply to your business and some don’t. Know before you export.
Several Federal, State, and local government agencies are involved in the supervision of the food supply. The main one is the FDA and many rules apply to food and medical devices. By reviewing the information on this website, or by contacting us, you can determine which rules are applicable to your products.
- Take steps to comply with all the FDA rules before you ship your first shipment to the USA. Make sure you comply with all the rules before you ship your first shipment.
The rules and complex and often confusing. We can help you with that process. In general, the facility where you process foods must be registered. You need to assign a person who can act as your US Agent for FDA purposes and you may have to review the labels used on your products.
- Update your information with the FDA, register new facilities and submit changes. You must notify FDA about every food shipment, including samples!
The FDA requires that you keep all information current and notify them about changes in ownership, food facilities, and products.
Q? Who Must Register?
A. A facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S.
Q? Who Can Register with the FDA?
A. If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf. A foreign facility’s U.S. agent may register the facility (21 CFR 1.230).
Q? When is Registration Required?
A. A facility must be registered before the facility begins manufacturing/processing, packing, or holding operations.
Q? Do non-U.S. based facilities need a US Agent?
A. Yes. The agent (1) must reside or maintain a place of business in the U.S. and (2) must be physically present in the U.S. The U.S. agent must be able to serve as the communication link between FDA and the foreign facility because FDA will contact the foreign facility’s U.S. agent for both routine registration matters and emergency situations. This means that the U.S. agent must be accessible to FDA 24 hours a day, 7 days a week.
Q? What are the consequences when a facility is not registered?
A. If food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food will be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food.
Q? Is the FDA food registration information public?
A. No. The list of registered facilities and registration documents, including information provided in those documents, are not subject to public disclosure under the Freedom of Information Act.