Beginning January 4, 2020, registrants must submit their registration or registration renewal to FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231). If FDA has granted a waiver under 21 CFR 1.245, the registrant may register or renew by mail or by fax. If you submit a registration or registration renewal by mail or fax, you must use the paper version of Form FDA 3537.
FDA strongly encourages electronic registration via the Internet, which will be quicker and more convenient than registration by paper for both facilities and FDA.
Regardless of the mode of submission, each registration must include the name and contact information for the facility and its parent company (if applicable); all trade names the facility uses; applicable food product categories as identified in 21 CFR 170.3; 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 the registration is authorized by the facility to register on its behalf; and if a foreign facility, the name of and contact information for the facility's U.S. agent, including emergency contact information, unless the facility designates another emergency contact. A domestic facility must provide emergency contact information.
You must submit all registration information in the English language except an individual's name, the name of a company, the name of a street, and a trade name may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet.
Registration by Paper (Mail or FAX)
You must register using Form 3537. Forms are available for download below. This PDF version of the form must be used for submission.
You may also obtain a copy of this form by writing to the U.S. Food and Drug Administration/Food Facility Registration, 5001 Campus Drive, HFS-681, College Park, MD 20993, or by requesting the form by phone at 800-216-7331 or 240-247-8804 .
- When you receive the form, you must fill it out completely and legibly and either mail it to the U.S. Food and Drug Administration/Food Facility Registration, 5001 Campus Drive, HFS-681, College Park, MD 20993, or FAX it to (301) 436-2804.
If any required information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or FAX number is legible and valid. If you choose to register by paper, we recommend that you fill out the PDF using a computer and print it to minimize possible delays from illegibility. If you have the full version of Adobe Acrobat 6.0, you can save multiple filled-out copies to your computer for printing. Forms are available for download below.
When returning a registration form for revision, FDA will use the means by which the form was received by the agency (i.e., by mail or FAX.).
- FDA will enter complete and legible mailed and faxed registration submissions into its registration system, as soon as practicable, in the order FDA receives them.
- FDA will then mail to the address or FAX to the FAX number on the registration form a copy of the registration as entered, confirmation of registration, and the registration number. When responding to a registration submission, FDA will use the means by which the registration was received by the agency (i.e., by mail or FAX.).
- If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in the Final Rule, §1.234.
- Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, CFSAN is providing the following electronic forms for notifiers to submit their registrations. The PDF form may be filled out online and then printed, or printed and filled out by hand. The forms may also be downloaded to the user's computer for data entry. Note: You must have the full version of Adobe Acrobat 6.0 to save a filled-out form to your computer. The completed PDF form may be printed and mailed to the U.S. Food and Drug Administration, Food Facility Registration, 5001 Campus Drive, HFS 681, College Park, MD 20993, or faxed to (301) 436-2804.
Food Facility Registration Form
DHHS/FDA Form No. 3537: (available in fill-in PDF for printing).
- DHHS/FDA Form No. 3537a: (available in fill-in PDF for printing).