March 13, 2015
The FDA is aware of inaccurate reports that the FDA has approved this product. To clarify, our evaluation focused solely on the non-alcohol ingredients added to the alcohol beverage versions of this product. We did not provide an approval, nor did we conduct any testing.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has the authority to review the formulation and labeling of distilled spirits products. TTB has consulted with the FDA with respect to the ingredients used in “Palcohol.” Consistent with the FDA’s authority, the agency evaluated the regulatory status of the non-alcohol ingredients added to these products. The FDA concluded that the use of ingredients in the proposed products was in compliance with FDA’s regulations. The agency notes that the ingredients used in the products are typical of ingredients found in many processed foods. The FDA does not have concerns that the ingredients, when added to the alcoholic beverage products, render the products adulterated under the Federal Food, Drug, and Cosmetic Act. As is the case of any multi-ingredient food product, the FDA may take further actions under its statutory authority if warranted by information it might acquire in the future about the product. However, at this time the FDA does not have a legal basis to block market entry of this product.