Alcohol | Registration/U.S. Agency
Alcoholic beverages are also “foods” as that term is defined by the Federal Food Drug and Cosmetic Act (FDCA), the Bioterrorism Act (BTA) and FDA regulations. Although the vast majority of alcoholic beverage labeling requirements are established by the Bureau of Alcohol Tobacco and Firearms (BATF), FDA still requires alcoholic beverage manufacturers, breweries, wineries, and warehouses to be registered under FDA’s Food Facility Registration Regulations before distributing alcoholic beverages in the U.S.
Similarly, food additives included in alcoholic beverages are still subject to FDA’s food additive regulations and Generally Recognized as Safe (GRAS) standards. Adding ingredients (such as amino acids, flavorants, and other functional food ingredients or additives) to alcoholic beverages is only permitted according to the FDCA and FDA regulations. BATF and the Tax and Trade Bureau (TTB) will defer to FDA with respect to food additives in alcoholic beverage formulations.
Foreign alcoholic beverage manufacturers must also appoint a U.S. Agent for FDA purposes when they register their manufacturing and processing facilities with FDA.
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