Ask Cari: What is the Wine Label Approval Requirements and Process by the Food and Drug Administration?

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The Food and Drug Administration does not regulate labeling for wine containing over 7% of alcohol.  The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) regulates labeling.  However, foreign alcohol manufacturers must register with the FDA per the FDA Food Facility Registration Regulation.

Regarding the FDA, when importing into the United States, commercial imports of all food and beverages (including wine) require filing “Prior Notice” with the FDA.  They must register with the FDA before goods are admitted to the United States.  To file Prior Notice, go to  Prior Notice was instituted in 2003 in response to the Bioterrorism Preparedness and Response Act of 2002.  The Prior Notice can be submitted through the Prior Notice System Interface (“PNSI”).

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