Drawback Tutorial

Drawback Tutorial Home TTB F 5154.1 Glossary/References Definitions TTB actions What is density? What is specific gravity? Important unit conversions Calculations Calculation of eligible alcohol Calculation of alcohol content of finished product Calculation Worksheets Unfitness for Beverage Purposes What makes a product unfit? 1% solutions Organoleptic Analysis Naming Nonbeverage Products Components of Formulas Format of submissions Common mistakes Listing Ingredients in Your Formula Identifying all sources of ethanol Limited ingredients Prohibited ingredients Information about solid extracts Artificial versus natural vanillin Flavors purchased from other manufacturers Compounded flavors manufactured in-house Acids as flavoring chemicals Botanicals allowed in flavors Submitting Samples with Formulas Revisions to Approved Formulas Special Products Food products containing ethanol Vanilla Extracts and Vanilla Flavors Example Formulas Simple mixture 1 Simple mixture 2 (including discussion about yield) Simple mixture 3 (includes a disapproved intermediate formula) Simple extract Washed extract (with multiple sources of ethanol) Dietary Supplements 1 Dietary Supplement 2

Food Products Containing Ethanol

Vanilla extracts and vanilla flavors are covered within the U.S. Food and Drug Administration’s regulations in 21 CFR  169.175 through 169.181.  It is important to note that a standard of identity vanilla product must adhere to the criteria outlined in the CFR.  If a product does not meet the standard of identity, it will be treated as any other flavor.  A few key points regarding the standard of identity are listed below:

• 1 unit of vanilla beans:  13.35 oz. of beans at 25% moisture
• 1X vanilla extract:  1 unit per gallon of finished product with a minimum 35% ethanol by volume.  The lower end of the range in item 10 defines the minimum.
• vanilla flavor:  1 unit per gallon of finished product (ethanol < 35% by volume)
• concentrated vanilla extract:  2 or more units per gallon with a minimum 35% ethanol by volume.  The lower end of the range in item 10 defines the minimum.
• concentrated vanilla flavor:  2 or more units per gallon (ethanol < 35% by volume)

Other ingredients that may be used in a vanilla extract:

glycerin

propylene glycol (please quantify)

sugar (including invert sugar)

dextrose

corn syrup

If any other ingredients are used then the product does not meet the standard of identity.

When submitting formulas for vanilla extracts/flavorings, bear the following in mind:

• Information regarding moisture content of the beans, manufacturing yield, fold, extraction steps, recovered ethanol, and disposal of the spent beans must be included on your submission.  We cannot process formula submissions with incomplete information.
• We subject 1 or 2 fold vanilla extracts to the organoleptic evaluation if they contain greater than 45% (by volume) alcohol.  This is because the amount of alcohol is more than is necessary to extract all of the odorous and sapid materials from the vanilla beans.