Overview & Background
Who must register?
Domestic facilities are required to register whether or not food from the facility enters interstate commerce.
Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
Examples of FDA-regulated Foods
Is there a registration fee?
What facilities are exempted from registration?
How long will this take?
Electronic Registration via the Internet
How to Register (or Update) a Food Facility Online
1. Computer System Requirements:
Is your computer secure? Before using FDA Industry Systems (FIS), FDA strongly encourages all users to have current antivirus and antispyware software installed on their computers to help ensure the privacy of the information being entered.
2. Create an Account
In order to log in , you must first have an account. If you do not have an account, you must create one or have one created for you(*). Once you have an account, you can log in to the online FDA Industry Systems to register your food facility.
When you create your own account, it may be used in order to register a single food facility or multiple facilities. When you create your own Account, you will create your own password and are immediately logged into the online systems after creating the account. More...
To create an Account, go to the Login screen and
Create an Account. Choose the Food Facility Registration
as the system you want access to, then fill out the series of screens
*Some companies may also wish to create subaccounts so additional personnel can help manage registration of one or more facilities. This is not required.
3. Register (or Update) a Food Facility
After you create your account, or when you come back later and log
in, choose the Food Facility Registration menu option.
Things you should know:
Before you start, we recommend that you collect all the information you will need. (See Fact Sheet and summary of fields in Form 3537.) If you need to look something up after you start, be aware that the system will automatically log you off after 30 minutes of inactivity. If you stop with a partially completed registration, none of the information will be saved, and you will need to start from the beginning when you log in again.
OMB Approval Number: 0910-0502
OMB Expiration Date: 05/31/2010
See OMB Burden Statement.
More Overview & Background
What Information Is Required?
What will happen if a facility fails to register by December 12, 2003?
If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise.
If the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) must arrange for moving it and promptly notify FDA of its location. The private parties are responsible for any costs associated with moving or storage of the food.
In December 2003 FDA published a Registration Compliance Policy Guide
(Revised August 2006).
This guidance outlines for FDA staff the agency's policy on enforcement of section
305 of the Bioterrorism Act and its implementing regulation.
How does one register?
The Agency strongly encourages electronic registration because it is faster and more convenient. The system the agency has developed can accept electronic registrations from anywhere in the world 24 hours a day, 7 days a week. A registering facility will receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are filled in. See Instructions.
Registration by mail may take several weeks to several months, depending on the speed of the mail system and the number of paper registrations that FDA will have to enter manually.
Form 3537 is available for download for registration by mail, FAX, or CD-ROM.More Help:
Instructions, Tutorials, and Questions and Answers for electronic Food Facility Registration, including Account Management
Contact information for online help