FDA 2020 Renewal - Frequently Asked Questions:

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FDA 2020 Renewal - Frequently Asked Questions:

Author:

30-Sep-20

FDA 2020 Renewal - Frequently Asked Questions:

What:

Every other year, FDA requires food facilities to confirm that the information FDA has on hand for the facility is complete, accurate and up to date.

When:

The registration period opens on October 1, 2020 and closes on December 31, 2020.

How:

Unless a waiver is granted for a paper submission, all renewals and new registrations are to be filed electronically via the [FDA FURL website].
Cost:

There is no fee to register or use the [FDA FURL website].

Short Cut?

If there are no changes in the information previously provided, FDA has created an abbreviate renewal process that allows the account owner to certify to this fact.

John S. Connor recommends that someone in the company with the requisite knowledge regarding the status of the facility review the registration information previously provided in its totality to ensure it is complete, accurate and up to date.

What food facilities must register with the FDA?

If you are the owner, operator, or agent in charge of either a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, you are required to register and complete all biennial renewals with the FDA.

What facilities are exempt from the registration requirement?

Establishments that meet the definition of a primary production farm, secondary activities farm, retail food establishment, restaurant, or nonprofit food establishment are not required to register. (These definitions can be found in 21 CFR 1.227

What happens if a food facility fails to renew their registration?

If a food facility fails to renew their registration timely, FDA will consider the food facility as having failed to meet their registration requirement which is prohibited by the US Federal Food, Drug and Cosmetic Act (FD&C Act). The registration is deemed expired and FDA will cancel any existing registration in its entirety.

Is it possible to obtain proof of my on-line registration and/or renewal?

Yes, it is possible to either print and/or save a copy of the registration information filed electronically.

We have a waiver to file a paper submission, what needs to be done?

Paper forms can be requested and submitted in the following ways: Fax: 301-436-2804

Mail: U.S. Food and Drug Administration Food Facility Registration (HFS-681) 5001 Campus Drive College Park, MD 20740

Email: Furls@fda.gov

Telephone: 1-800-216-7331 or 240-247-8804

When contacting the FDA by phone or email during the registration period, please anticipate a delay due to volume.

Are there any resources available to help facilities with this process?

The FDA has a number of resources available to help facilities register and renew their registration. Recently, FDA released two guidance documents to help food facilities meet their registration requirements.

The first is a seventh edition of a guidance to help the owners and operators of food facilities better understand the registration requirements and reflects updates made to the registration provisions in the FD&C Act that were made following the passage of FSMA.

The second is a supplemental draft guidance to the seventh edition which includes questions and answers that clarify FDA’s thinking about the registration requirements when multiple entities are sharing physical space.

The following materials are also available:

Registration of Food Facilities

Food Facility Registration User Guide: Biennial Renewal

Biennial Renewal of Food Facility Registration: Information for Startups and Small Entities