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66 | AmErICAn DIstIllInG InstItutE
ingredients or use production processes that would “change the character, composition, class or type” of a distilled spirit. TTB’s application of this rule fluctuates over time. Nevertheless, a few generalizations can be drawn from TTB’s long-term practices. Products of distillation alone (e.g., whiskey, brandy, vodka, rum) generally do not require a formula approval. On the other hand, TTB currently requires formula approvals for the following classes and types of distilled spirits:
n Liqueurs and cordials
n Gin, if botanicals are added after distillation
n Vodka subject to carbon filtration
n Flavored distilled spirits like flavored vodka, rum, brandy or whisky
n Any distilled spirit specialty product, which includes any distilled spirit that does not fit into a TTB-recognized class and type designation
In order to obtain a formula approval, a distiller must complete a formula application on TTB Form 5100.51, available at http://www.ttb.gov/forms/f510051.pdf. In boxes 6 and 7, the distiller must include a simplified recipe of a single batch that lists each ingredient along with a quantity or range of the ingredient’s use in the batch, the alcohol content of any ingredients that contribute alcohol to the finished product, and a brief description of the production process. If the product contains flavors, the application should identify the TTB or ATF approval number for the flavor and include a Flavor Ingredient Data sheet, also called a FID sheet, completed by the flavor manufacturer that identifies the amount of certain ingredients that are subject to use limits in finished products.
TTB requires the submission of two executed formula applications to its Advertising, Labeling & Formulation Division (ALFD) located at its headquarters office in Washington, D.C. TTB does not impose fees on the submission of formula applications. Applications can be filed by mail, overnight delivery, or in person by the applicant or via several trade associations, law firms and consultants. In person delivery often saves time and reduces the risk that information might be lost as the application winds its way through the general mail and TTB’s internal mail-routing system. During regular business hours, ALFD’s customer service team is available for questions by industry members (202.927.8140).
upon receiving a formula application, the assigned ALFD formulation specialist reviews it for compliance with federal law. Among the issues that a formulation specialist examines are whether: (1) the listed ingredients are generally recognized as safe (GRAS) under the standards enforced by the federal Food & Drug Administration, (2) the listed ingredients and processes can be used in the production of the class and type of distilled spirit identified on the formula application; and (3) TTB has approved the use of the particular ingredients and processes listed. Processing times for formula applications vary depending on ALFD’s work-load, the complexities of the formula, and other factors. Currently, it can take ALFD three to four weeks to review a formula application and issue an approval or rejection. Delays of several months, however, are not uncommon. If ALFD issues a formula rejection, additional time is required for the distiller to modify and re- submit the formula until ALFD issues an approval. As a result, a formula rejection can be

























































































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