TTB Public Guidance

When submitting an alcohol beverage formula, you should include a specification sheet for each ingredient that is made from more than one component.

For example, if your formula contains a fruit juice that was made from water, apples, and sugar, a specification sheet that lists those components should be submitted for the fruit juice.

Many ingredients in alcohol beverage formulas do not require specification sheets. For instance:

• You don't need to send a specification sheet for an ingredient that is made from a single ingredient or component. For example, ingredients such as malted barley, grapes, hops, cane sugar, or spearmint do NOT require specification sheets.
• You also don't need to send a specification sheet for a compounded flavor; instead, you should submit a flavor ingredient data sheet (FID sheet) from the flavor manufacturer.

We use ingredient specification sheets to understand the ingredients in a formula, so we can complete a thorough application review. Some ways we use the information on a spec sheet are:

• To determine if any flavors are used in the ingredient that would affect the labeling designations for the alcohol beverage product
• To determine if any FDA limited ingredients are contained within the ingredient that may result in limitations being exceeded, which would result in a need for you to reformulate your product
• To determine if any alcohol is present in the ingredient
• To confirm that the ingredient does not contain a component that requires FDA review

 

There are several ways to obtain a specification sheet for the ingredient used in your alcohol beverage product. They include, but are not limited to:

• The shipment documentation for the product
• The manufacturer's website
• The ingredient listing on the product's label

 

A spec sheet should list all components (including solvent(s), limited ingredients, and colors) used to make the ingredient. Components are commonly listed in descending order of predominance by weight; however, quantities are not required. The spec sheet may be as simple as a listing of all the different components used to make the ingredient.

Ingredient specification sheets may also contain additional information about the ingredient, such as numeric quantities of the ingredient's components, results of microbiological testing, shelf life, or storage requirements, but we do not typically use these details to evaluate the ingredient.

Make sure the ingredient specification sheet contains the list of components used to make the ingredient. Then, submit it as an attachment in Formulas Online (after you enter your ingredient information, or within the Docs / Links tab).

If you are submitting a paper application, send the ingredient specification sheet with TTB Form 5100.51 as an attachment.

There is no specific format for ingredient specification sheets. Here are three different examples of acceptable specification sheets:

	Example 1 This spec sheet includes the basic information about the ingredient.
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	Example 2 This example is a copy of an ingredient label. It includes the Nutrition Facts panel in addition to the basic list of ingredients.
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	Example 3 This spec sheet includes a lot of supplemental information, including laboratory results and storage recommendations, in addition to the basic information about the ingredient.
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