FAQs: US FDA Certification (Food Facility Registration)

According to the US Federal Food, Drug, and Cosmetic Act (FD&C Act), all businesses involved in the production, processing, packaging, or storage of food (including food additives and dietary supplements) – collectively referred to as food facilities – must complete registration with the US Food and Drug Administration (FDA). These businesses are also required to update their registration every even-numbered year between October 1 and December 31 and ensure that the FDA is permitted to conduct facility inspections within the scope allowed by the FD&C Act.

Detailed information on the US FDA food facility registration process, including examples of food categories that require registration and the necessary documentation, can be found here. In this article, CIRS Group has summarized common issues encountered during registration, drawing from the Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition), to provide a useful reference for companies.

Q1: Do new food facilities need to wait until October 1 of a biennial renewal year to register?

A1: No. The owner, operator, or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the United States must register before the facility begins such activities (21 CFR 1.230). If the initial registration is submitted prior to October 1, of a biennial renewal year, a renewal must still be submitted during the period beginning on October 1 and ending on December 31.

Q2: Will a food facility be issued a new registration number during the registration renewal process?

A2: No. A food facility will not be issued a new registration number when it renews a current registration.

Q3: If I am the owner, operator, or agent in charge of multiple food facilities, do I have to provide separate unique facility identifiers (UFIs) for each of my facilities?

A3: Yes. The registration for each facility must include a UFI recognized as acceptable by FDA (see21 CFR 1.232(a)(2)). Currently, the FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI.

Q4: Can foreign facilities belonging to the same parent company use different US agents for registration?

A4: Yes. Each foreign facility must identify, as part of the registration process, its US agent, and there is no requirement that facilities belonging to the same parent company utilize the same US agent. Also, any or all facilities belonging to the same parent company may designate the same US agent for registration purposes.

Q5: I have changes to my registration information. Must I update my registration now, or can I wait until the beginning of the biennial registration renewal period beginning on October 1 of each even-numbered year?

A5: The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s registration to FDA within 60 calendar days of a change to any of the required registration information previously submitted under 21 CFR 1.232 (21 CFR 1.234(a)). If a change occurs to a facility’s previously submitted information before the start of, or during the biennial registration renewal period, a registrant can submit an update for such change(s) as part of the facility’s registration renewal. However, the update must be submitted within 60 calendar days of the change. If a facility submits an update to FDA before the start of the next biennial registration renewal period, which takes place from October 1 – December 31, of each even-numbered year, the facility will still be required to submit a registration renewal to FDA during the biennial registration renewal period

Q6: If my facility is a warehouse/holding facility, do I have to constantly update the food product categories in my registration if this information frequently changes?

A6: For warehouse facilities engaged in ongoing operations that frequently change food product categories, these facilities may select all of the food product categories that are normally part of their operations. If the warehouse has updates to the food product categories it handles, the facility is required to update its registration in accordance with 21 CFR 1.234.

Q7: Will the FDA require food facility registration numbers to be displayed on food labels?

A7: No. The FDA does not require food facilities to list the registration number related to food production, processing, packaging, or storage on food labels. In fact, the FDA discourages food companies from including the registration number on labels to prevent misuse by others.

Q8: Is the information included in a food facility’s registration or relating to such registrations available to the public?

A8: The FDA does not make the registration information of food facilities available to the public (21 CFR 1.243), but it does provide registration statistics. As of March 26, 2024, there are 91,225 registered domestic food companies in the United States and 128,886 registered foreign food companies. Among these, Chinese food companies have the highest number of registrations (12,752 from mainland China, 2,141 from Taiwan, 496 from Hong Kong, and 8 from Macau).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.