FAQ: FDA Food Facility Registrations and Renewals
WHAT IS THE FDA FOOD FACILITY REGISTRATION REQUIREMENT?
The FDA requires all domestic and foreign facilities that manufacture, process, pack, or hold food, beverages or dietary supplements for distribution in the United States to register with the FDA. Registration, which includes consent to an FDA inspection, is a threshold requirement for exporting foods from an overseas market to the US and importing and selling foods in the U.S.
WHEN MUST FACILITIES REGISTER OR RENEW?
Facilities must submit an initial registration to FDA only one time, but it must be done before manufacturing, processing, packing or holding food for consumption in the U.S. Facilities must renew their registration every even numbered year between October 1 and December 31.
WHAT FOODS ARE SUBJECT TO THE REGULATION?
- 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 chewing gum)
- live food animals
- food for animals (i.e. pet food, pet treats and chews, animal feed)
WHAT FOODS ARE EXCLUDED FROM THE REGULATION?
- food contact substances
WHAT IS INVOLVED IN REGISTERING?
Information on the initial registration includes:
- name and contact information for the facility and parent company
- name and contact information for the owner, operator or agent in charge
- a statement certifying that the information submitted is true and accurate, and that the person submitting registration is authorized to register on its behalf.
- if a foreign facility, the name and contact information for the facility's U.S. agent
- assurance that FDA will be permitted to inspect the facility at the times and in the matter permitted by the FDA.
There is an abbreviated process for registration renewals.
WHAT IS A US AGENT?
Foreign food facilities must designate a U.S. agent for communication with the FDA. This must be a person, partnership, corporation or association who has a place of business or residence and is physically present in the United States. The U.S. Agent serves as a communication link between the FDA and the foreign facility.
WHAT IF A FACILITY FAILS TO REGISTER OR RENEW?
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.Failure to register, renew your registration, update required elements or cancel registration is a prohibited act. FDA can bring civil or criminal action in Federal court to prosecute responsible persons.