FDA Prior Notice Required for Imported Alcohol
FDA Prior Notice Provides Key Information about Imported Alcohol
The US Food & Drug Administration (FDA) requires that a Prior Notice of Imported Foods be filed before any food product–including alcoholic beverages–be imported into the United States. The FDA Prior Notice is required regardless on the quantity of products being imported. For instance, a FDA Prior Notice is required even to import a small number of bottles for participating in a beer, wine, or distilled spirits festival or competition and not for sale. In addition, a separate FDA Prior Notice is required for each separate product code (such as a UPC) and for each different product size and supplier.
Generally, the FDA Prior Notice requires specific information about each imported product and the non-US source of the product. This includes the following:
- Product name, code, and container size
- Product country of origin
- Manufacturer’s name, address, and FDA Registration Number
- Shipper’s name, address, and FDA Registration Number
- Manner of shipment to the US
- Recipient’s name and address
- Anticipated shipping date
The FDA Prior Notice can be filed by any party involved in importing the product, or their agent, using the FDA’s Prior Notice System Interface (PNSI) system. However, each party–manufacturer, non-US shipper, and US importer–must have an FDA Registration Number.
Foreign Suppliers Must Register with FDA
FDA registration is required for all processing facilities that produce food and beverage sold in the United States. See Brewers’ Law 101: Federal FDA Food Facility Registration. For non-US manufacturers and shippers, registering with the FDA often requires help and coordination by the US importer. This is especially the case when working with officers of the manufacturer or shipper who do not understand English-language directions and are unfamiliar with US government agencies. For instance, at the time of writing, the process of confirming a non-US manufacturer’s Food Facility Registration Number involves the FDA sending a “receipt code” to the manufacturer’s designated email address, and the receipt code must be approved by logging into the PSNI system with the same email address.
Filing the FDA Prior Notice for each new product can be made easier when the non-US manufacturer and shipper appoints a U.S. Agent. After a manufacturer or supplier is registered, an authorized U.S. Agent can process the FDA Prior Notices for their products.
Other Federal and State Requirements for Alcohol Imports
The FDA Prior Notice is not a substitute for the approval requirements that apply to all alcoholic products sold in the United States. When alcoholic beverage products are imported to the United States for sale, the importer must also handle compliance with the federal TTB’s certificate of label approval (COLA) and formula approval requirements, as well as the requirements of each state in which the products will be sold. For more information for importers, see Alcoholic Beverage Importers: Federal & Florida Licensing.
Do you have any questions about the FDA’s Prior Notice requirement? Contact us at firstname.lastname@example.org to schedule a consultation with a beverage attorney.
Because we’re attorneys: Disclaimer. Updated July 17, 2022.