October 17, 2017 TTB Seal TTB G 2017-7  

 

TTB Public Guidance

   

 

Malt Beverage Example Formulas

To help you better understand what information, and how much detail, to include in an alcohol beverage formula application, we've created some example applications for fictitious products. These example formulas are shown as they would appear in Formulas Online, and each includes the supporting documentation (one or more of: Flavor Ingredient Data (FID) sheet, Limited Ingredient Calculation Worksheet, Ingredient Specification Sheet) that should be submitted with the formula.

Each example also includes some information on how the product could be labeled, based on the ingredients and method of manufacture of the product.

Malt Beverage Example 1- Malt Beverage Specialty

This example is a malt beverage that is brewed and then flavored with a combination of whole, natural ingredients and one compounded flavor that contains added alcohol. A preservative is used within the limits set by FDA and additional coloring has been added. This product does not conform to any particular malt beverage designation and is therefore classified as a malt beverage specialty (for formula purposes) and is required to be labeled with a truthful and adequate statement of composition under 27 CFR 7.24.

Note that a limit exists regarding the amount of alcohol that can be added to the product from flavors or other nonbeverage ingredients. See 27 CFR 7.11 and 27 CFR 25.15. Both the formula and the calculation worksheet reflect the added alcohol.

Formulas Online Entry for Example 1 (Malt Beverage Specialty)

Based on the ingredients used to make this product, the applicant included the following supporting documentation with the formula:

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Click to enlarge a view of the formula for Example 1 (Malt Beverage Specialty) as it would appear in Formulas Online.

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Supporting Documentation for Example 1 (Malt Beverage Specialty)

Based on the ingredients used to make this product, the applicant included the following supporting documentation with the formula:

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  1. Flavor Ingredient Data (FID) sheet for the Natural and Artificial Coffee Flavor
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2-Column Layout
  1. Limited ingredient calculation worksheet
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A FID sheet is required for each of the compounded flavors in the product.

The limited ingredient calculation worksheet is required in this instance for the following reasons:

  • To determine that the flavor is "natural" for labeling purposes; and

  • To ensure compliance with 27 CFR 7.11 and 27 CFR 25.15. In the case of malt beverages with an alcohol content of less than or equal to 6% by volume, no more than 49% of the overall alcohol content of the finished product may be derived from added flavors and other nonbeverage ingredients containing alcohol.

Labeling Information for Example 1 (Malt Beverage Specialty)

This product contains three natural flavors and one artificial color (caramel) that must be disclosed in the statement of composition on the label. TTB will provide a simple, general statement of composition for the product label when the formula application is approved and returned to the applicant. The suggested statement of composition that we would provide for this malt beverage specialty is:

"Malt Beverage with Natural Flavors and Caramel Color"

The industry member could either use this generic statement of composition to meet the requirement for class/type statement on the label, or create a more specific labeling statement that discloses the specific flavors as well as the coloring additive. For example:

"Malt Beverage with coconut and cinnamon, coffee flavor, and caramel color"

"Malt Beverage with coffee and other natural flavors and artificial color"

Other variations of the statement of composition are also possible.

Malt Beverage Example 2- Malt Beverage Specialty with Three Flavor Groups

This example demonstrates that one formula can be used to cover three different versions, or flavor profiles, of a finished malt beverage.

This product, which is classified as a malt beverage specialty, is made from a base of pale ale flavored with freshly squeezed lemon juice. The base malt beverage is exempt from formula approval, since fresh lemon juice has been deemed a traditional ingredient under TTB Ruling 2015-1. The brewer then adds sodium benzoate (within the accepted limits found in 21 CFR 184.1733) as a preservative.

The base product is then combined with one of three flavor sets and color additives (FD&C Blue No. 1, titanium dioxide, and caramel), which requires formula approval. None of the flavor profiles conforms to any particular malt beverage designation and the product is therefore classified as a malt beverage specialty (for formula purposes) and is required to be labeled with a truthful and adequate statement of composition under 27 CFR 7.24.

Formulas Online Entry for Example 2 (Malt Beverage Specialty with Three Flavor Groups)

page layout Click to enlarge a view of the formula for Example 2 (Malt Beverage Specialty with Three Flavor Groups) as it would appear in Formulas Online.

Supporting Documentation for Example 2 (Malt Beverage Specialty with Three Flavor Groups)

Based on the ingredients used to make this product, the applicant included the following supporting documentation with the formula:

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  1. Flavor Ingredient Data (FID) sheet for the Natural Mango flavor
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2-Column Layout
  1. FID sheet for the Natural Mint flavor
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2-Column Layout
  1. FID sheet for the Natural and Artificial Pineapple flavor
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2-Column Layout
  1. FID sheet for the Natural and Artificial Coffee flavor
     
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2-Column Layout
  1. FID sheet for the Natural and Artificial Tropical Fruit flavor
     
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2-Column Layout
  1. FID sheet for the Natural Blueberry flavor
     
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  1. Three limited ingredient calculation worksheets (one for each flavor group):
2-Column Layout Flavor Group 1 2-Column Layout Flavor Group 2 2-Column Layout Flavor Group 3

A FID sheet is required for each of the compounded flavors in the product.

The limited ingredient calculation worksheets are required in this instance for the following reasons:

  • To determine that the flavors are "natural" for labeling purposes;

  • To ensure that the limited ingredients contained in the individual compounded flavors do not exceed the overall limits when used in combination; and 

  • To ensure compliance with 27 CFR 7.11(a)(2) and 25.15. In the case of malt beverages with an alcohol content of more than 6% by volume, no more than 1.5% of the volume of the malt beverage may consist of alcohol derived from added flavors and other nonbeverage ingredients containing alcohol.

Flavor Combinations for Example 2 (Malt Beverage Specialty with Three Flavor Groups)

We permit multiple flavor combinations or groups to be shown in one formula as long as:

  • The combinations are clearly stated in the formula

  • The flavors are used only in the combinations shown

  • Each combination is categorized the same way for labeling purposes (i.e., "natural" or "artificial")

For example, one combination cannot be categorized as "artificial" while the second combination is "natural." The combinations need to match so that we can provide an accurate suggested labeling statement of composition for any product that can be made from the formula.

Labeling Information for Example 2 (Malt Beverage Specialty with Three Flavor Groups)

This product contains two natural flavors and artificial colors (a certified color (FD&C Blue #1) and caramel color) that must be disclosed in the statement of composition on the label. TTB will provide a simple, general statement of composition for the product label when the formula application is approved and returned to the applicant. The suggested statement of composition that we would provide for this malt beverage specialty is:

"Malt Beverage with Natural Flavors and Artificial Colors"

Alternatively, the industry member could create a more specific statement of composition for the flavor groups. One possible statement of composition for Flavor Group 1 is:

"Pale ale with mango and mint flavors and artificial colors"

Other variations of the statement of composition are also possible for each of the different flavor profiles.

Additionally, because the compounded flavors in this product contain added alcohol, a statement of alcohol content must appear on the brand label, as required by 27 CFR 7.22(a)(5).