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FDA Reminds Food Facilities of Biennial Renewal Requirements

Every two years between October 1 and December 31, owners, operators, or agents in charge of a domestic or foreign facility that manufactures, processes, packs, or holds food for consumption by humans or animals in the United States are required to renew their registration with the FDA. Additionally, facilities that are qualified facilities must submit an attestation supporting their qualified facility status during the same time period.

Food Facility Registration (FFR)

Food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless FDA has granted them a waiver that allows for registration by mail or by fax. There is no fee associated with registration or renewal. FDA will consider the registration to be expired for any facility that fails to renew by December 31, 2026. For guidance on the renewal process, see:

To register, facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the food facility registration (FFR) submission. The UFI is used to verify that the facility-specific address associated with the UFI is the same address associated with the facility's registration. Currently, the FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI for food facility registration. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) and can be obtained or verified by visiting Dun & Bradstreet's website.

For questions contact FDA staff by phone at 1-240-247-8804 or by email at FURLS@fda.gov

Qualified Facility Attestations

During the same biennial renewal period, qualified facilities must complete and submit their qualified facility attestation (QFA). A qualified facility is generally a business that, because of its very small size, is required to meet only modified requirements under the Food Safety Modernization Act (FSMA). A facility may meet the definition of a qualified facility in either the Preventive Controls for Human Food (PC Human Food) or Preventive Controls for Animal Food (PC Animal Food) Rule.

To submit their attestation, a facility must have a valid food facility registration. Attestation forms can be submitted electronically via the Qualified Facility Attestation Module at https://www.access.fda.gov/.

While electronic submission via the QFA module is preferred, if you must complete your form manually, please email the form directly to FDA using the following address: FDA-QFA-Program@fda.hhs.gov. Additional information on qualified facilities and submitting attestations can be found in the links below:

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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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