Brewers’ Law 101: Federal FDA Food Facility Registration
The manufacturing of food products, including alcoholic beverages, is regulated by the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety and other areas.
Before manufacturing or selling alcoholic beverages (or any other food product), unless an exception applies, the food processor must register with the FDA. Registration does not require specific approval by the FDA. There is no registration fee. Since 2020, registering a new food processing facility with the FDA is a two-step process. Step 1 involves obtaining a Unique Facility Identifier (UFI). Step 2 involves filing a short online registration form.
According to the Brewer’s Association, small breweries that primarily sell directly to consumers (rather than to distributors) may be exempt from the FDA’s registration requirement.
Step 1: Obtaining a Unique Facility Identified (UFI)
As the name implies, a UFI is a unique number required to identify each food processing facility, whether in the United States or not. As of this writing, the UFI is the same as a DUNS number for the facility. Instead of operating its own facility identification and numbering system, the only UFI accepted by the FDA is the number assigned to a facility by registering through the privately administered Dunn & Bradstreet Data Universal Numbering System (DUNS). See the FDA’s Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (March 2021).
DUNS is a freely available, online registration system. Any business can obtain a DUNS number by registering with Dunn & Bradstreet. In order to comply with the FDA’s food processor registration requirement, all alcoholic beverage suppliers, located inside or outside the United States, must first register with Dunn & Bradstreet.
Step 2: Register through the FDA Industry Systems (FIS)
Once the DUNS number is assigned, the alcoholic beverage plant (aka food facility) must register using the online FDA Industry Systems (FIS). After creating an online FIS user account, registration requires completion of a short registration form. Information required to be completed on the registration form includes the following:
- Facility Name
- Physical Address
- Emergency Contact Information
- Trade Names
- United States Agent
- Product Categories
- Owner, Operator or Agent in Charge Information
For foreign food facilities, identification of the United States Agent is particularly important. The US Agent must reside in the United States or maintain a physical place of business in the United States. The US Agent is responsible to assist the FDA in communicating with the foreign establishment and assist the FDA in scheduling inspection of the foreign facility, if required. If the FDA is unable to contact the operator of the foreign facility directly, the FDA may provide information or documents to the US Agent.
Biennial Renewal of FDA Registration
The FDA registration of all food processing facilities is required to be renewed in the last quarter of every even year. As of this writing, the next biennial renewal period will be from October 1, 2022 through December 31, 2022. No matter when a food processing facility was originally registered with the FDA (even, for instance, September 30, 2022), a renewal is required to be filed during each biennial renewal period.
Renewing the FDA registration is very similar to the initial registration process. During the biennial renewal period, the person responsible for filing the original food facility registration should again log into the FIS account. Select the option to review and file the facilities biennial renewal. If any changes need to be made to the information provided in the initial registration or the last biennial renewal, the information can be changed and submitted.
Do you have any questions about registering your alcoholic beverage facility with the FDA? Contact us at firstname.lastname@example.org to schedule a consultation with a beverage attorney.
Because we’re attorneys: Disclaimer. Post updated November 20, 2022.