USA Food & Drug Administration (FDA) Reminds Facilities to Register or Renew their Food Facility Registration

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) governs the registration and renewal of food facilities with the FDA. Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack or hold food for human consumption in the United States or destined for the United States to register with the FDA. Furthermore, Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA, to renew such registrations during the period beginning on October 1st and ending on December 31st of each even-numbered year.

Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024. There is no fee associated with registration or renewal. Owners, operators or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless they have received a waiver that allows for paper submission.

Note that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31 of the even-numbered year, the registration is considered expired and will be removed from your account.

In addition, all facilities must include a unique facility identifier (UFI) recognized as acceptable to FDA with the registration submission "To" date, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet. DUNS numbers can be obtained or verified by visiting D&B’s website.

D&B and FDA Presentation on Biennial Food Facility Registration Renewal

 You can also find Biennial Registration Renewal Step-by-Step System Instructions here.

If you have any further questions, please contact the Food Facility Registration Data Management Support Services (FFRDMSS): by phone at 1-800-216-7331 or 240-247-8804; or by email at FURLS@fda.gov.

 For consultation services and assistance in complying with this program, you may also reach out to us at: customs_compliance_group@am.kwe.com

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