Drawback Tutorial

We are providing you with this tutorial to show a more effective way to fill out TTB Form 5154.1.  Guidelines for submissions of nonbeverage product formulas to the Nonbeverage Products Laboratory and sample calculations for items 9 & 10 are provided for the most common types of submissions.  We have found that roughly 80 to 90% of the submissions fall under two categories:

1. Simple mixtures (with and without filtration)
2. Washed extracts of essential oils

Compounded flavors are the most frequently encountered by the Laboratory and will serve as examples for simple mixtures.  Sample calculations for washed extracts are also included.  Even if your product does not strictly adhere to these formats, please review the calculations because much of the information can be applied to other types of products.

The first twelve topics cover an array of issues that should help you better understand the requirements for approval of a nonbeverage product formula.  The rest of the topics include example calculations for the scenarios discussed above.

Questions and comments regarding this tutorial can be sent to the laboratory staff at the following e-mail address drawback@ttb.gov. Please do not send status requests to this e-mail.

TTB F 5154.1

Important definitions

TTB actions on formulas

Naming nonbeverage products

Format of submissions (entries in item 13)

TTB Form 5154.1 - common mistakes

Classes of ingredients

Identifying all sources of ethanol

Limited ingredients

Prohibited ingredients

Important information about solid extracts

Artificial versus natural vanillin

Flavors purchased from another manufacturer (purchased intermediates)

Intermediate ingredients manufactured in-house

What makes a product unfit?

Important information about 1% solutions

MNBP Protocol for Organoleptic Analysis

Submitting samples with TTB Form 5154.1

Revisions to Approved Formulas

Acids as flavoring chemicals

Food products containing ethanol

Vanilla Extracts and Vanilla Flavors

Botanicals allowed in flavors

What is density?

What is specific gravity?

Important unit conversions

Calculation of items 9 & 10

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

Calculation Worksheets

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Important links

1% lists - solutions of natural or artificial flavor chemicals unfit at 1% (wt/wt) in 95% v/v ethanol

0.1% list - solutions of flavor chemicals unfit at 0.1% (wt/wt) in 95% v/v ethanol (Coming Soon)

Tolerance table - used to determine range in item 10 for TTB Form 5154.1

The following can be accessed at the Lab’s Limited Ingredients Web page. 

• Approved colors
• The FDA list of limited ingredients
• TTB limited ingredients
• The FDA list of prohibited ingredients

Other sources of information:

• Prohibited ingredients
• 21 CFR PART 189 – Substances prohibited from use in human food
  
  
• FDA Web site on colors

• All natural flavors approved by FDA as GRAS (generally recognized as safe)

• The Code of Federal Regulations

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Important definitions

GRAS: Generally Regarded As Safe - Click here to go to the FDA webpage for more information.

Nonbeverage products:  The products in this class must meet two criteria.  They must be unfit for beverage purposes and they must fall within one of the six eligible product classes.  The six classes are foods, flavors, flavoring extracts, medicines, medicinal preparations, and perfumes.

Proof:  A measure of the amount of ethanol in distilled spirits. Proof is twice the percentage of ethanol by volume.  For example, 95% ethanol by volume is 190 proof ethanol.

Proof gallon:  The official definition (as found in 27 CFR 19.11) is a gallon of liquid at 60 degrees Fahrenheit which contains 50 percent by volume of ethyl alcohol having a specific gravity of 0.7939 at 60 degrees Fahrenheit referred to water at 60 degrees Fahrenheit as unity, or the alcoholic equivalent thereof.

To calculate proof gallons from wine gallons, use the following formula:

(Proof ÷ 100) × wine gallons = proof gallons

Example:      (80 proof ÷ 100) × 1 wine gallon = 0.8 proof gallons

Wine gallon:  Common measure of volume containing 128 liquid ounces, regardless of ethanol content.

Absolute ethanol:  Also called 200 proof ethanol or anhydrous ethanol.  It is ethanol with all of the water removed.

Neutral grain spirits:  A clear liquid distilled at high ethyl alcohol content. The term neutral refers to the substance's neutral odor and lack of characteristic taste. The grain from which it is derived can be any of the common cereal grains.

Natural:  Please see 21 CFR 101.22 for a detailed discussion of food labeling requirements.

Artificial (including nature identical):  Please see 21 CFR 101.22 for a detailed discussion of food labeling requirements.

Drawback:  The portion of excise taxes paid on distilled spirits returned to the manufacturer of nonbeverage products when tax-paid alcohol is used to produce approved products unfit for beverage purposes.

Unfit for beverage purposes: The average person would not mistake the product for an alcoholic beverage.

Intermediate products (TTB definition): Products to which all three of the following conditions apply: (1) they are made with taxpaid distilled spirits, (2) they have been disapproved for drawback, and (3) they are made by the manufacturer exclusively for its own use in the manufacture of nonbeverage products approved for drawback.

Intermediate products (Industry definition): Compounded flavors used within another flavor.  They may be purchased or manufactured in-house.  For the purposes of this tutorial, we will use the industry definition.

Recovered spirits: Taxpaid spirits that have been salvaged, after use in the manufacture of a product or ingredient, so that the spirits are reusable.

5010 Tax Credit: For a complete explanation, please visit the Beverage Alcohol page.

Density: Mass divided by volume.  Please see the density section for a complete explanation.

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TTB Actions on Formulas 

Disapproved: Fit for beverage purposes. 

• Domestic: The flavor is not eligible for the drawback of taxes paid.  The flavor can be used only as an in-house intermediate in a product that is subsequently approved.  It cannot be sold.

• International: The flavor can be used in an alcoholic beverage only if the flavor and beverage are both manufactured outside the U.S.  However, the 5010 tax credit cannot be claimed by a beverage manufacturer on the portion of the disapproved flavor.

Approved: Unfit for beverage purposes.  The flavor is eligible for the drawback of taxes paid.  The flavor can be used inside or outside the U.S., and an alcoholic beverage manufacturer can claim the 5010 tax credit on the flavor.

No Action: Unfit for beverage purposes.  There is no ethanol directly added.  However, the product may contain ethanol.  The 5010 tax credit can be claimed on the flavor by the beverage manufacturer.

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Naming nonbeverage products

In general, products are named based on the U.S. Food and Drug Administration's (FDA) regulations.  Those guidelines are listed first.  If flavors are used in alcoholic beverages, TTB has slightly more liberal guidelines for labeling of flavors used in alcoholic beverages.  Those are listed second.

FDA Guidelines

• Natural Flavors:  must contain a natural source of the named material and must be an all-natural product.  Any flavor materials present must be derived from the named ingredient.  For example, a natural strawberry flavor must contain a natural source of strawberry and all flavor materials must be derived from strawberry.
  
  
• Natural Flavors WONF:  must contain a natural source of the named material but may also contain other natural flavor materials.  These other natural flavors do not need to be derived from the named material.  For example, a natural strawberry flavor WONF must contain a natural source of strawberry but may also contain natural flavor chemicals not necessarily derived from strawberry (e.g. natural ethyl butyrate).
  
  
• Natural & Artificial Flavors:  must contain a natural source of the named material but may also contain artificial flavor materials.
  
  
• Natural Type Flavors, Natural Bases and Natural Keys:  natural flavors that do not contain the named ingredient.  For example, natural strawberry type flavor contains all natural ingredients but does not contain a natural source of strawberry.
  
  
• Artificial Flavors:  predominant flavor is from artificial ingredients.

NOTE:  Any products containing artificial ingredients cannot have “WONF” in the name!

TTB Guidelines

• Natural & Artificial Flavors with 0.1% artificial topnote:  flavors containing not more than 0.1% artificial topnote are considered natural when used in alcoholic beverages.  The calculation of the amount of artificial material does not include artificial vanillin, ethyl vanillin, artificial maltol nor ethyl maltol. 
  
  
• When flavors are submitted for drawback of tax, the name should comply with FDA requirements (i.e. Natural & Artificial) even though TTB will consider them natural when they are used in alcoholic beverages.
  
  
• Natural & Artificial Flavors with greater than 0.1% artificial topnote:  considered for alcoholic beverage labeling purposes to be artificial.
  
  
• Other considerations:  TTB has limitations for artificial vanillin, ethyl maltol, artificial maltol and ethyl maltol in alcoholic beverages.  If these limitations are exceeded, the finished beverage will be considered an artificial product.

Vanillin:  40 ppm
Ethyl vanillin:  16 ppm
Maltol:  250 ppm
Ethyl maltol:  100 ppm

Keep in mind that these limitations are in the finished alcoholic beverage; not in the flavor.  The actual amount present in the beverage will be calculated based on the use rate of the flavor.

• Wines containing < 7% by volume ethanol are subject to the FDA labeling guidelines listed above.

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Format of Submissions (entries in item 13)

For the purpose of processing, the most important information on the form is usually located in box 13.  The format and quality of the information in this box is critical to the review process.  Incorrect, incomplete, or poorly formatted information are the major reasons for delayed processing or return of submissions.  An example of a well formatted entry in box 13 is shown below:

The following items make this formula easier to process:

1. Ingredients are listed individually or in specific groups, such as natural esters.
2. Limited ingredients are identified and quantified. 
3. The weight of each ingredient or ingredient class is given along with the units. 
4. Ingredients that contain ethanol list the volume of the ingredient (the density of the ingredient can also be provided if the volume is not known). 
5. The ethanol content of each ingredient that contains ethanol is also provided.
6. A yield is given with the same units as the ingredients (pounds and gallons), and a simple statement about the process (simple mixture) is provided.

Using this information, the TTB chemist can review this formula relatively quickly (including verifying items 9 and 10).

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TTB Form 5154.1 - Common Mistakes

1. Mixed units, no units, or improper units on quantities – Frequently, we receive formulas that use percentages for the ingredient quantities or several different units of measure (mixed metric and English units, mixed English units, etc.).  While these problems do not necessarily require us to return the formula to the submitter, dealing with the conversions often adds a significant amount of time to processing the formula.  Submitters should try not to use percentages when expressing quantities.
2. No yield or very little yield information – Generally we need the yield expressed in both mass and volume units.  At the very least, the mass and density of the final product are needed to process the formula.
3. Improper grouping of flavor chemicals – Do not group artificial and natural flavor chemicals.  Additionally, separate flavor classes (see section on classes of ingredients for more information).  Please note that some acids are not considered flavor chemicals (see the section on acids).
4. Failure to disclose solvents, colors, and limited ingredients in purchased flavor intermediates, such as solid extracts and essences.
5. Use of obscure names or shorthand to identify ingredients – Trade names and shorthand may or may not be recognizable to us.  Please try to use the chemical name or provide vendor information that will help us identify the ingredient.  If you do not have the chemical name, please include a FEMA number.
6. Failure to provide TTB number for purchased intermediate flavors – If the intermediate flavor contains ethanol (>0.5% by volume), it should have a TTB number.  Some possible exceptions to this are essences, distillates, and some simple extracts.  This information should be available to you on the FIDS provided by the vendor.  It is your responsibility to provide this information to the TTB.
7. Making blanket statements such as “all ingredients FEMA GRAS” instead of listing the ingredients in box 13 - The Laboratory requires much greater detail on formula submissions.

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Classes of Ingredients

All ingredients used in flavors must be approved for food use by the U.S. Food and Drug Administration (FDA).  The FDA lists these ingredients on their Web site at:

• Summary of GRAS Notices

• EAFUS:  A Food Additive Database

The following are types of materials that may be grouped together:

• Essential oils and absolutes
  
  
• Acids
  
  
• Flavor chemicals (aldehydes, ketones, esters, alcohols, etc.)
  
  
• Fruit juices

Products containing ethanol, limited ingredients, and colors must be listed separately. 
Essences, distillates, and solid extracts commonly contain these ingredients.  For essences and distillates, the ethanol content (%v/v) must be provided.  If the essence or distillate does not contain ethanol or any limited preservatives, please indicate this on TTB Form 5154.1.  For solid extracts, limited ingredients (usually propylene glycol) must be quantified and colors must be identified.  If the solid extract does not contain limited ingredients or colors, please indicate this on the form.  If you choose to group these products, please be aware that you are obligated to provide aggregate levels of ethanol and/or limited ingredients for each group.

All FDA limited ingredients must be listed and quantified separately.  Similarly, the four TTB limited ingredients (artificial vanillin, ethyl vanillin, artificial maltol, and ethyl maltol) must be listed and quantified separately.

To understand grouping flavor chemicals, it is important to understand naming conventions:

Aldehydes:  usually have aldehyde in the name or end with “al.”  Examples include benzaldehyde, acetaldehyde, citral, and trans 2-hexenal.

Ketones:  usually end with “one.”  Examples include furanone, acetophenone, and ß-ionone.

Esters:  usually end with “ate.”  Examples include ethyl acetate, amyl butyrate, and cinnamyl formate.

Alcohols:  usually end with “ol.”  Examples include ethanol, citronellol, and geraniol. (Note: do not group ethanol with other alcohols)

Common solvents include propylene glycol, triethyl citrate, benzyl alcohol, triacetin, and glycerin.

Some Important Tips:

• The most predominant ingredient(s) must be disclosed when grouping ingredients.

• While it is not required, including FEMA numbers for flavor chemicals can be useful to the chemist reviewing the formula, particularly if he/she doesn’t recognize the name used for the chemical.  Below is an example of a highly effective way to present ingredient information.

  Example:  Total formula is 100 lbs
  Benzaldehyde (FEMA # 2127, 1.23 lbs)
  and other FEMA GRAS natural aldehydes …………………………………… 2.0 lbs

In this example, the class of flavor chemicals, natural aldehydes, is given along with the total weight of the group of ingredients.  The predominant flavor chemical, benzaldehyde, is given along with its weight and FEMA number. 

• When grouping chemical classes, a significant amount of the components must be disclosed.  When the total of the grouping is 1 – 10% of the total formula, at least 20% must be disclosed. 

  In the example above, 20% of 2.0 lbs is 0.4 lbs.  At least 0.4 lbs must be disclosed.  The example above has more then 20% disclosed and is therefore acceptable.

• Ingredients should not be grouped together in excessive quantities.  For any grouping of chemical classes greater than 10% of the total product, at least half of the total group needs to be disclosed.  As the percentage of flavor chemicals increase, so should the amount disclosed.  For instance, the following line item in box 13 would be unacceptable:

  Example:  Total formula is 100 lbs
  cis-6-nonenal (FEMA # 3580, 2 lbs)
  and other FEMA GRAS artificial aldehydes …………………………………… 50 lbs

In this case, 96% of the ingredients under this line item are unspecified.  With the total amount of ingredients in the formula at 100 lbs, this would mean that almost half the ingredients were undisclosed.  Significant changes in the formulation could affect its status as a nonbeverage product and poses difficulty in verifying compliance.

• Below is an example of a larger grouping with the appropriate amount disclosed.

  Example:  Total Formula is 100 lbs
  Butyraldehyde (FEMA #2219, 8.3 lbs), cis-6-nonenal (FEMA #3580, 5.4), citral (FEMA #2303, 3.3 lbs)
  and other FEMA GRAS artificial aldehydes…………………………………… 30 lbs

In this example, the grouping is 30% of the total in the formula.  At least 50% must be disclosed, in this case 50% = 15 lbs.  More than one component may need to be listed in order to disclose the appropriate amount.  The most predominant component is listed first followed by the next most predominant component in order until components listed add up to at least half of the total amount in the group (in this example 17 lbs or 56.67%).

Things to remember:

• Make sure any component that makes the product unfit is also disclosed.
• Natural and artificial flavor components must be listed separately.
• The same requirements apply to other groupings of materials.  For example, nat. flavor chemicals, essential oils, juices, etc.
• If grouping by flavor chemical, the group may contain aldehydes, ketones, esters, alcohols, etc.  It cannot contain oils, absolutes, acids, solvents, or juices.
• In some cases, even if the appropriate amount has been disclosed, it still may be necessary to return the formula for more information.

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Identifying All Sources of Ethanol

All sources of ethanol must be listed separately along with the percent ethanol (v/v) or proof, the weight, and volume added to the formulation.  Note:  If spirits other than neutral spirits, such as rum, are used in your formulation, please state the type of spirits and the corresponding proof in box 2 on the form.

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Limited Ingredients

Limited ingredients must be identified in the formulation regardless of the source.  This means that limited ingredients from in-house intermediates and purchased intermediates must be listed and quantified.  This can be done with a minimum of effort by simply listing the percent by weight of each limited ingredient for each intermediate formulation listed, or providing a TTB number.  Frequently, this information can be obtained from the manufacturer’s specification sheet or Flavor Ingredient Data Sheet (FIDS).  The following is an example of a line item in box 13: 

Chickory Solid Extract (10% PG by wt)…………………..0.9 lbs

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Prohibited Ingredients

Please see 21 CFR Part 189 for a comprehensive list of substances prohibited from use in human food.

Important Information About Solid Extracts

This is such an important issue that it needs to be repeated.  Solid extracts may contain caramel color and/or propylene glycol.  When this is the case, identify caramel color and quantify the amount of propylene glycol.  If the solid extract is free of these materials, please state that on the formula.  A specification or ingredient data sheet may be submitted, but it must provide the information mentioned above.  The following is an example of a line item in box 13:

Fenugreek Solid Extract (10% PG by wt, Caramel Color)………1.0 lbs

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Artificial Versus Natural Vanillin

It is the position of the TTB that the only source of natural vanillin is from vanilla beans.  All other sources (clove, turmeric, lignin, eugenol) are considered artificial and should be labeled accordingly on TTB Form 5154.1.

The Nonbeverage Products Laboratory has received notification from the U. S. Food and Drug Administration (FDA) that the fermentation process for the manufacture of vanillin as submitted to them by Rhodia, Inc. has been determined to be a natural process resulting in a natural product.  This applies only to the specific process submitted by Rhodia and not to any other processes for the production of vanillin.  For further information, please contact the FDA.

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Flavors Purchased From Another Manufacturer (Purchased Intermediates)

We regularly receive formulas containing purchased intermediates (often compounded flavors) without supporting information. 

The following information is required for purchased intermediates:

• Predominant ingredients must be identified and quantified on the formula.
• All limited ingredients must be listed and quantified. 
• Colors must be listed. 
• If the product contains ethanol, the ethanol content in volume must be provided.
• Please be sure to provide the manufacturer and TTB number of the product (if it has been submitted to TTB). 
• A specification or ingredient data sheet may be submitted, but it must provide the information mentioned above.  The manufacturer of the product may be directed to fax the information directly to us, referencing your TTB number.

Note:  It is important to point out that information on limited ingredients, ethanol content, and the TTB number of your product is not proprietary and must be provided to customers when requested.  In situations where disclosing the quantities of FDA or TTB limited ingredients would reveal the majority of the product, the information may be provided directly to the Nonbeverage Products Laboratory.  This can be accomplished by the manufacturer of the intermediate submitting the formula on TTB Form 5154.1.

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Intermediate Ingredients Manufactured In-House

The requirements for in-house intermediates, for the most part, are the same as the requirements for purchased intermediates. The rules for disclosure of ethanol, predominant ingredients, colors, and limited ingredients must be followed.  However, these intermediates do not need to be approved by TTB.

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What Makes a Product Unfit?

In the absence of materials that will make the product more palatable (sugar, glycerin, high fructose corn syrup, etc.), the following commonly used ingredients when present in the stated amounts will, in most instances, make a product unfit for beverage purposes.  This list is intended only as a guide and is not applicable to all products.

Expansive lists of flavor chemicals that make a formula unfit at 1% by weight are presented on the lists for artificial and natural flavors. Please note that the chemicals on these lists will make a product unfit (at the prescribed levels) in the absence of masking agents such as sweeteners.

A calculation worksheet based on the above guidelines is available for download.  This worksheet will calculate the amount needed of an ingredient to make your product unfit based on the ethanol content and the amount of that ingredient, in the units used in the table, that is in the product.

Download Calculation Worksheet
pounds / gallons
grams / milliliters

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Important Information About 1% Solutions

The artificial and natural flavors lists name chemicals that make a product unfit at 1% by weight. Often, companies will prepare 1% solutions of flavor chemicals for use as intermediates in compounded flavors.  It is important to note that compounded flavors containing these 1% solutions are not necessarily unfit.  This is because the 1% solution will be combined with other ingredients resulting in a flavor that contains less than 1% of the particular flavor chemical.

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MNBP Protocol for Organoleptic Analysis

For nonbeverage products, organoleptic testing is performed for the purpose of determining whether the average person would mistake the product for an alcoholic beverage.  Unlike tasting protocols for finished products, where the detection of slight variations or subtleties in flavor might be important, the determination of fitness for beverage purposes requires the panelist to consider if the product has flavor qualities that would clearly make it unpalatable to the average person.

Tasting protocol:  Performed under ambient conditions

1. Samples that contain more than 15% alcohol by volume are diluted to that level with tap water before taste paneling.  Dilution is based on the upper end of the range for alcohol content in item 10 on form TTB F 5154.1.
2. Samples that contain 15% alcohol by volume or less are tasted without dilution.
3. Six or more panelists are required for organoleptic analysis.
4. Two-thirds of the panelists must agree that the sample is unfit for beverage purposes.
5. Results of the taste panel are to be recorded in box 13 of form TTB F 5154.1 with the following statement:

“This product was found to be unfit for beverage purposes.  It was subjected to organoleptic analysis by a taste panel of ____ panelists, ____ of whom agreed on the determination.”

For example: “This product was found to be unfit for beverage purposes. It was subjected to organoleptic analysis by a taste panel of six (6) panelists, four (4) of whom agreed on the determination.”

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Submitting Samples with TTB Form 5154.1

The following guidelines should help the submitter decide when it is appropriate to send a four ounce sample of their product along with TTB Form 5154.1.  Sending a sample when it is not required adds unnecessary burden to the review process and can delay action on your formula.

You should not send a sample when:

• The product does not contain ethanol.
• The formula shows that the product meets the guidelines as outlined in the section describing what makes a product unfit. (for products produced in the United States).

You should send a sample when:

• Formula does not list significant amounts of flavor chemicals.
• Only essences, concentrates, extracts are listed.
• Less than 10% by weight essential oil in a washed extract.
• Formula contains masking agents such as sugar, high fructose corn syrup, glycerin, juices.
• Ingredient making formula unfit is not listed on formula.
• Product is not produced in the United States (even if unfit by guidelines)
• Product is a sauce/syrup - ethanol is not more than 12% (v/v) and residual solids greater than or equal to 60 grams per 100 cubic centimeters.
• Vanilla extracts:

• Less than 1 fold
• 1X or 2X with ethanol greater than 45% (v/v) in item 10

Note: Ideally, the submitter would list the specific chemical(s) that make the product unfit on the form.  This could eliminate the need to submit a sample.

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Revisions to Approved Formulas

Use the following guidelines for the TTB number when submitting revisions of approved formulas.

The same TTB number may be used when:

• There is a change in the yield due to a change in the manufacturing process.
• Correcting an error or an omission in a non-limited ingredient.
• Changing the formulation from an approved formula to one with no eligible alcohol (No Action).

A new TTB number is needed when:

• A color is added or removed.
• A TTB or FDA limited ingredient is added or removed.
• The quantity of a TTB or FDA limited ingredient is changed.
• Changes in the formula affect the labeling status of the product.
• Changes in the formula affect the beverage character of the product.

Note:  The same guidelines apply to revisions of disapproved formulas.  If trying to make an unfit product, a new TTB number is needed.  If there are only minor changes with no change in the fitness of the product, the same TTB number may be used.

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Acids as Flavoring Chemicals

Volatile acids are used for flavoring purposes and must be considered when naming products.  This is particularly important for “natural” compounded flavors, where the source, natural or artificial, of the acid must be noted.  If you do not state explicitly that a volatile acid ingredient is natural, the TTB will assume that it is artificial.  Fixed acids lack either taste or aroma and therefore are not considered flavors.  The following tables list common volatile and fixed acids (acidulants).

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Food Products Containing Ethanol

27 CFR Section 17.133  Food product formulas.

Formulas for nonbeverage food products on TTB Form 5154.1 may be approved if they are unfit for beverage purposes. Approval does not authorize manufacture or sale contrary to state law. Examples of food products that have been found to be unfit for beverage purposes are stated below:

1. Sauces or syrups. Sauces, or syrups consisting of sugar solutions and distilled spirits, in which the ethanol content is not more than 12 percent by volume and the sugar content is not less than 60 grams per 100 cubic centimeters (also called milliliters).
2. Brandied fruits. Brandied fruits consisting of solidly packaged fruits, either whole or segmented, and distilled spirits products not exceeding the quantity and ethanol content necessary for flavoring and preserving. Generally, brandied fruits will be considered to have met these standards if the container is well filled and solidly packed.  The ethanol in the liquid portion cannot exceed 23 percent by volume, and the liquid portion cannot exceed 45 percent of the volume of the container.
3. Candies. Candies with alcoholic fillings, if the fillings meet the standards prescribed for sauces and syrups by paragraph (a) of this section.  The purpose of the ethanol in these products is to flavor the candy.
4. Other food products. Food products such as mincemeat, plum pudding, and fruit cake, where only sufficient distilled spirits are used for flavoring and preserving; and ice cream and ices where only sufficient spirits are used for flavoring purposes. Also food adjuncts, such as preservatives, emulsifying agents, and food colorings, that are unfit for beverage purposes and are manufactured and used, or sold for use, in food.

Note: Neutral grain spirits do not qualify, as they do not contribute to the taste or odor of the product.

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Vanilla Extracts and Vanilla Flavors

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:

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

Two important tips:

• 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.

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Botanicals Allowed in Flavors

All botanicals used in flavors must be approved for food use by the U.S. Food and Drug Administration (FDA).  Although it is not a comprehensive list, the following table provides the GRAS status of a number of botanical ingredients.  Please be aware that the status of these products could change at any time.  You can find comprehensive lists of approved ingredients in 21 CFR  Parts 172.510, 182.10, and 182.20.  The EAFUS list on the FDA Web site also lists botanicals.

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What is Density?

Density is how heavy something is for its size (how much it weighs divided by how big it is). So, something that is small and heavy has a high density.

Density is mass divided by volume. It's usually measured in grams per milliliter or pounds per gallon. To work out the density of something, divide mass (how much it weighs), by volume (how much space it takes up). 

Example:

A gallon of water weighs 8.33 pounds, therefore the density is 8.33 pounds/gallon.

It is important to note that density varies with temperature (TTB uses densities at 60 degrees Farenheit).  The gauging manual provides densities for ethanol:water solutions across a broad temperature range.

Some important densities to remember:

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What is Specific Gravity?

The specific gravity of a substance is a comparison of its density to that of water.  It is calculated by dividing the density of the material by the density of water at 4 degrees Celsius.  Because specific gravity is a ratio, it is a unitless quantity.

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Important unit conversions

1 gallon = 3785 milliliters

3.785 liters = 1 gallon

1 gallon = 128 fluid ounces

1 pound = 453.5924 grams

1 pound = 16 ounces

Please visit the NIST Web site for unit conversions.

Some sample calculations are provided on the following websites
Disclaimer:  When selecting the links below you are going to a site that TTB does not control and whose privacy policies may differ. TTB does not endorse these Web sites or their contents.

University of Arizona Units and Unit Measure

One of These Things Is Not Like the Other – A Discussion of Units

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Calculation of items 9 & 10

Simple Mixture 1

In this example, items 9 and 10 are relatively easy to calculate because all of the ethanol is coming from one source (see the first line in item# 13) and the yield is 100% (simple mixture).

Step 1.Start with the ethanol: 7.0 pounds have been added to the mixture.  To convert pounds to gallons, 7.0 pounds is divided by the density (in pounds per gallon) to give the volume: 7.0 ÷ 6.7943 = 1.03 gallons again, this is: pounds ÷ (pounds per gallon) = gallons Always be careful about units (do not mix metric and English units.) Step 2. Once the value in terms of volume has been calculated, you need to compensate for the fact that the ethanol is only 95% pure (the other 5% is water).  You must multiply the volume you calculated in (1) by the percent ethanol to get the volume of absolute ethanol: 1.03 gallons × 0.95 = 0.979 gallons of absolute ethanol

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Step 3. To calculate item 9, you would divide 0.979 gallons of absolute ethanol by the yield (9.5 gallons):

0.979 gallons ÷ 9.5 gallons = 0.103 or 10.3%

For this formula, items 9 and 10 are calculated the same way.  The tolerance is applied only to item 10 as described in the tolerance table for a simple mixture.

Click here to find worksheets to help you calculate items 9 and 10.

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Simple Mixture 2 (including discussion about yield)

This simple mixture is a bit more complex. There are two ingredients that contribute ethanol to this formula.  The 190 proof ethanol is eligible for drawback and will be used to calculate item 9.  The Raspberry Essence also contains ethanol but it is ineligible for drawback.  However, it must be included in the calculation of item 10.

Step 1. Item 9 calculation – as in the previous example, first you need to convert pounds to gallons: 25.0 pounds ÷ 6.7943 pounds/gallon = 3.68 gallons next, multiply 3.68 gallons by the % ethanol to get the volume of absolute alcohol: 3.7 gallons × 0.95 = 3.50 gallons of absolute ethanol the last step is to divide by the yield 3.50 gallons of absolute ethanol ÷ 11.5 gallons = 0.304 or 30.4% for item 9. Step 2. Item 10 calculation – The ethanol from the Raspberry Essence must be added to the ethanol that was calculated for item 9.

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The density of the Raspberry Essence is used to convert the weight to volume. You need only to multiply the volume of the Raspberry Essence by the volume percent ethanol of 3%.

0.51 gallons × 0.030 = 0.015 gallons of absolute ethanol

Add the gallons of absolute ethanol from (1) and (2) together:

0.015 + 3.50 = 3.515 gallons of absolute ethanol

divide this by the yield to get the ethanol content for item 10:

3.535 gallons of absolute ethanol ÷ 11.5 gallons = 0.306 or 30.6%

As in the previous example, the tolerance for item 10 is set according to the guidelines established in the tolerance table for a simple mixture.

Filtered products - The calculation of item 10 would not change.  However, item 9 would be calculated using the final (actual) yield.

In general, the yield of a filtered product is lower than that of a simple mixture (simple mixtures = 100% yield).  We refer to a 100% yield as the theoretical yield because it assumes that none of the product is lost during processing.

For simple mixtures it is easy to see why we can use a 100% yield (there are no processing steps to significantly affect the final yield). However, filtrations expose the product to more processing steps and, as a result, increased probability of product loss.

A formula for a filtered product (that is submitted to us) should include both theoretical and final yields.

So why do we use the final yield to calculate item 9?

This is important because it is not simply the ethanol in the final product that is calculated, it is the ethanol used in the manufacturing process.  This is especially important for products where some or all of the ethanol was lost due to processing.

Why do we use the theoretical yield to calculate item 10?

When filtration is the only other processing step, the ethanol content in the final product will be determined by the proportioning of miscible ingredients during mixing (even though there will be a loss of product to the filtration step).

Since filtration is not a selective process for dissolved components we would not expect the ethanol level to change.

Click here to find worksheets to help you calculate items 9 and 10.

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Simple Mixture 3 (includes a disapproved intermediate formula)

Note: disapproved formulas must be manufactured in-house

This is basically the same formula as in Simple mixture 2 except the Raspberry Essence has been changed to a disapproved formula and the product is filtered.  The ethanol from disapproved formulas is eligible for a drawback claim if it is used in an approved formula as an intermediate (it must be claimed in item 2 of TTB Form 5154.1).  In this case, both the Raspberry Essence and the 190 proof ethanol are eligible for drawback and will be used to calculate item 9.

Step 1. Item 9 calculation – First source of eligible alcohol - calculate the absolute ethanol coming from the 190 proof ethanol 25.0 pounds ÷ 6.7943 pounds/gallon = 3.68 gallons multiply by the % ethanol 3.68 gallons × 0.95 = 3.50 gallons of absolute ethanol Second source of eligible alcohol - calculate the gallons of absolute ethanol from the disapproved Raspberry Essence by multiplying the volume by the % ethanol 0.51 gallons × 0.050 = 0.026 gallons of absolute ethanol Add the gallons of absolute alcohol together and divide by the actual yield (the actual yield is the amount of product left after processing… in this case, filtration)

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(3.50 gallons of absolute ethanol + 0.026 gallons of absolute ethanol) ÷ 11.2 gallons = 0.315 or 31.5%

Step 2. Item 10 calculation –

In this example, the absolute gallons of ethanol are calculated the same as for item 9

3.50 gallons of absolute ethanol + 0.026 gallons of absolute ethanol = 3.526 absolute gallons of ethanol

divide this by the theoretical yield to get the ethanol content for item 10:

3.526 gallons of absolute ethanol ÷ 11.5 gallons = 0.307 or 30.7%

Since this is a filtered product one would use the tolerance established for filtrations in the tolerance table.

Click here to find worksheets to help you calculate items 9 and 10.

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Simple extract

Calculating items 9 and 10 for an extract is more complex than the previous examples.

Step 1. Item 9 calculation – all of the eligible alcohol comes from the 190 proof ethanol (pounds of ethanol are converted to gallons as in the previous examples): first, multiply the volume of 190 proof ethanol (8.83 gallons) by the % ethanol 8.83 gal × 0.95 = 8.39 gallons of absolute ethanol next, divide by the final yield low end of yield range 8.39 gallons of absolute ethanol ÷10.8 gallons = 0.777 or 77.7% high end of yield range 8.39 gallons of absolute ethanol ÷11.5 gallons = 0.730 or 73.0% This provides the range for the eligible alcohol in item 9.

Click on the image to enlarge

Step 2. Item 10 calculation - For this, a determination of the concentration of the ethanol in the starting menstruum must be made (ethanol and water along with other dissolved components (not the oil!)).

This is the volume of the starting menstruum and is used in the following equation to calculate item 10

Item 10 = (gallons of absolute ethanol) ÷ (volume (in gallons) of starting menstruum)

8.39 gallons of absolute ethanol ÷ 12.49 gallons = 0.672 or 67.2%

For extracts, the tolerance used for filtered products is applied to item 10 (see the tolerance table).
 

Why use the starting menstruum? 

The oil does not add significant volume to the final product because it will not dissolve to an appreciable extent in the water: ethanol mixture.  Once the oil is removed, the ethanol content will be determined by the proportions of the soluble ingredients (in this case, the water and ethanol).

Click here to find worksheets to help you calculate items 9 and 10.

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Washed extract (with multiple sources of ethanol)

Calculating items 9 and 10 for this extract is more complex than the previous examples.

Step 1. Item 9 calculation – Locate the eligible ethanol in the formula.  The only source is the 190 proof ethanol (pounds of ethanol are converted to gallons as in the previous examples).  Note that the Lemon Extract has a TTB approval for drawback.  first, multiply the volume of 190 proof ethanol (8.10 gallons) by the % ethanol 8.10 gallons × 0.95 = 7.70 gallons of absolute ethanol Next, divide by the final yield low end of yield range 7.70 gallons of absolute ethanol ÷ 11.3 gallons = 0.680 or 68.1% high end of yield range 7.70 gallons of absolute ethanol ÷ 12.0 gallons = 0.642 or 64.2%

Click on the image to enlarge

This provides the range for the eligible alcohol in item 9.

Step 2. Item 10 calculation - For this, a determination of the concentration of the ethanol in the starting menstruum must be made (ethanol and water along with other dissolved components (not the oil!)).

Use the sum (12.39 gallons) in the denominator of the following equation:

Item 10 = [gallons of absolute ethanol] ÷ [volume (in gallons) of starting menstruum]

Where gallons of absolute ethanol = 190 proof ethanol + ethanol from TTB # 8180

Divide this number by the volume of the starting menstruum to get item 10 7.79 gallons of absolute ethanol ÷ 12.39 gallons = 0.629 or 62.9%

For extracts, the tolerance used for filtered products is applied to item 10 (see the tolerance table).

Click here to find worksheets to help you calculate items 9 and 10.

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Dietary Supplements 1

In this example, the starting menstruum is just ethanol and water.

95 fl oz. + 35 fl oz. = 130 fl oz.

90.25 fl oz. ÷ 130 fl oz. = 0.6942 or 69.42%

The tolerance used for dietary supplements for item 10 is always +/- 5. 

Note:  The value of cannot be less then zero or higher then the theoretical value (ex:  if 190 proof ethanol is used, item #10 cannot be higher then 95%).

Click here to find worksheets to help you calculate items 9 and 10.

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Dietary Supplements 2

In this example, the starting menstruum is ethanol, the water added and the water from the wet herb.

Using the moisture content, the volume of water contributed by the herb can be determined.

35 wt oz. (weight of herb) × 0.195 (moisture content) = 6.825 wt oz. of water from herb
6.825 wt oz. = 6.555 fl oz. water from herb

Starting menstruum:
80 fl oz. (ethanol) + 30 fl oz. (water) + 6.555 (water from herb) = 116.555 fl oz.

76 fl oz. ÷ 116.555 fl oz. = 0.6521 or 65.21%

The tolerance used for dietary supplements for item 10 is always +/- 5. 

Note:  The value of cannot be less then zero or higher then the theoretical value (ex:  if 190 proof ethanol is used, item #10 cannot be higher then 95%).

Click here to find worksheets to help you calculate items 9 and 10.

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