What is Food Facility Registration?
The U.S. Food & Drug Administration requires various parties manufacturing, packing, holding and importing foods to register and renew their registrations every two years.
When must facilities register or renew?
The current registration and renewal period opened October 1, 2018, and will close December 31, 2018.
What type of foods are subject to the registration requirements?
The following foods are included:
- dietary supplements and dietary ingredients
- infant formula
- beverages (i.e. alcoholic beverages and bottled water)
- fruits and vegetables
- fish and seafood
- dairy products and shell eggs
- raw agricultural commodities for use as food or components of food
- canned and frozen foods
- bakery goods, snack goods, and candy (including shewing gum)
- live food animals
- food for animals (i.e. pet food, pet treats and chews, animal feed)
The following foods are excluded:
- food contact substances
Who is exempt from the registration requirements?
- private residences of individuals
- non-bottled water drinking water collection and distribution establishments and structures (i.e. municipal water systems)
- transport vehicles that hold food only in the usual course of their business as carriers
- primary production farms
- secondary activities farms
- retail food establishments
What are the responsibilities of a U.S. Agent?
Foreign facilities must name a U.S. Agent. This may be an individual, partnership, corporation or association who has a place of business or residence in the U.S. and is physically present in the U.S. They serve as a communication link between the FDA and the foreign facility, and will be considered the emergency contact for a registered foreign facility.
What are the consequences of non-registration?
FDA can bring civil or criminal action in federal court to prosecute responsible persons. Also, if a foreign facility is required to register but fails to do so, food from the facility will be held at the port of entry or a secure facility until registration is completed.
What are the consequences of non-renewal?
FDA will consider a registration to be expired if the registration is not renewed. Facilities with expired registrations will face the same consequences as those that do not register.