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17 October 2016

Two New TTB Rulings Issued On General Use Formulas

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McDermott Will & Emery

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These changes represent a modest but helpful attempt to reduce the number of formula and PIA submissions filed by the industry.
United States Food, Drugs, Healthcare, Life Sciences

On September 29, the Alcohol & Tobacco Tax & Trade Bureau (TTB) issued two new Rulings announcing the creation "general use formulas" for certain distilled spirits and agricultural wines. These general use formulas permit the production or importation of these products without the need to first obtain an approved formula (for domestic products) or a pre-import approval (PIA – for imported products) from TTB.

TTB Ruling 2016-2 exempts from the regulations' formula and PIA requirements most "agricultural wines," a category that generally encompasses wines fermented from materials other than fruit. Most notably, honey wine (mead) is now exempt from the requirement to file for a formula or a PIA prior to applying for label approval and/or introducing the product into commerce.

TTB Ruling 2016-3 exempts certain categories of distilled spirits from formula and PIA requirements. For certain categories of spirits made with less than 2.5 percent "harmless coloring, flavoring, or blending materials," certain specific materials are now authorized without the need to obtain formula or PIA approval. The categories and materials are:

  1. Vodka made with sugar (up to 2g per liter) and/or citric acid (up to 1 g per liter);
  2. Rum made with sugar, brown sugar, molasses and/or caramel;
  3. Certain types of whiskies made with sugar, caramel and/or wine; and
  4. Certain types of brandy made with sugar, caramel, fruit from the same fruit used to make the brandy and/or wine fermented from the same fruit.

These changes represent a modest but helpful attempt to reduce the number of formula and PIA submissions filed by the industry.

Two New TTB Rulings Issued on General Use Formulas

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