The short answer: Yes.
Wineries, breweries, distilleries, cideries, meaderies, and other producers of alcohol beverages are required to be registered with the FDA for food facility registration purposes if they manufacture, process, package, or hold food for human consumption in the U.S. With respect to FDA food facility registration purposes, “food” is defined to include alcohol beverages such as wine, beer and malt beverages, distilled spirits, sake, ciders, meads, etc.
Alcohol beverage facilities are not exempt from the requirement to register as food facilities nor are they exempt from the Food Safety Modernization Act (“FSMA”), although they are currently excused from some of the more burdensome provisions of FSMA. In general, both domestic and foreign facilities that manufacture, process, package, or hold alcohol beverages for consumption in the U.S. are required to register with FDA and renew their registration every even-numbered year (i.e., 2016, 2018, 2020, etc.).
Every domestic winery, brewery, distillery, cidery, meadery, or other producer, blender, or bottler of alcohol beverages should be registered with the FDA.
For international facilities, the regulations are somewhat more specific, but generally if a facility manufactures, processes, packages or holds food that will be consumed in the U.S. (without further manufacturing or processing outside the U.S.), that facility needs to be registered with the FDA and maintain a U.S.-based Agent.
For more information about this topic, contact Robert Lehrman.
