Facility Registration requires that all domestic and foreign facilities which manufacture, process, pack or hold food for consumption in the U.S. — by humans and/or animals — must register with the FDA.
- Domestic facilities are required to register whether or not food from the facility
enters interstate commerce.
- Foreign facilities are required to have a U.S. agent who acts as a liaison between the facility and the FDA for both routine and emergency communications.
FedEx Trade Networks can assist you with all the critical requirements of the registration process, serve as your agent with the FDA, and help you avoid the problems of denied entry.
Frequently Asked Questions
What types of facilities require registration with the FDA?
The following facilities must be registered with the FDA:
- Domestic facilities — whether or not food from the facility enters interstate commerce.
- Foreign facilities — unless food from that facility undergoes further processing or packaging by another foreign facility before export to the US (labeling is not a further process).
The registration requirement applies to each covered facility, not to firms or companies as a whole (e.g. A company with ten facilities must register each one separately).
Must "mixed-type" facilities be registered with the FDA?
If an establishment is a combination of a facility subject to the FDA's registration rule as well as an exempt facility, the facility is required to register. For example, a farm who grows apples and manufactures/processes the apples into juice for sale to a distributor must register.
Who must register with the FDA?
The owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption in the US must register with the FDA.
An individual authorized by the owner, operator, or agent in charge of a domestic or foreign facility* that manufactures, processes, packs or holds food for human or animal consumption in the US can complete registration with the FDA.
*For registration purposes, a foreign facility must designate a U.S. agent who lives or maintains a place of business in the US and that is physically present in the U.S.
Who is exempt from registration?
There are several exemptions from registration, including:
- Private residences of individuals.
- Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
- Transport vehicles that hold food only in the usual course of business as carriers.
- Farms that have facilities in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.
- Restaurants that prepare and sell food directly to consumers for immediate consumption including pet shelters, kennels and veterinary facilities that provide food directly to animals.
- Retail food establishments, such as groceries, delis, and roadside stands that sell food directly to consumers as their primary function.
- Non-profit food establishments which are charitable entities that meet the Internal Revenue Code and that prepare or serve food directly to the consumer.
- Fishing vessels that harvest and transport fish.
- Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture (USDA).
How often do I have to register?
You only have to register each facility once.
What happens if my registration information changes after submission?
Any registration information updates must be submitted to the FDA within 60 days of initial registration.
How can I register with the FDA?
FedEx Trade Networks can help make the registration process hassle-free. We will register your domestic and/or foreign facilities using one of the following approved methods:
- Electronic registration (preferred method) will be available worldwide, 24 hours a day, 7 days a week.
- Paper registration accepted if Internet access is not readily available.
How do I register my foreign supplier(s) with the FDA?
Foreign facilities must be registered utilizing the same tools as domestic facilities. Foreign facilities require U.S. agency representation, which is a service offered by FedEx Trade Networks. In order to register your foreign facilities, FedEx Trade Networks will forward an agency agreement to the foreign facility and enter into a separate and distinct relationship with that party.
Is there a charge for registration and/or U.S. agency representation?
Yes. For registration of domestic facilities, the charge will include registration activity, update of FedEx Trade Networks databases, and reminder notices for updates. Maintenance activities will be billed on an as-needed basis. U.S. agency representation for registration of foreign facilities will be charged on an annual basis. The charge will include registration activity, update of FedEx Trade Networks databases, and conducting FDA mandated agency activities.
For a quotation of prices, please call 1.800.249.2953.