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Drawback Tutorial

What Makes a Product Unfit?

Determining whether your product is unfit for beverage purposes has become much easier. The Nonbeverage Products Laboratory has developed several tools to streamline the process and remove the majority of subjectivity. Please use these guidelines and provide an unfit for beverage statement with your formula submissions.

Click here to view a flow chart to help you decide which set of guidelines is relevant to your flavor/flavoring product.

Flavor Unfitness Worksheet

New guidelines have been created based on the Flavor and Extract Manufacturers Association's (FEMA) GRAS™ average maximum use levels. The average maximum use levels for flavor chemicals have been extracted from GRAS lists and can be used to make a product unfit. Any applicable material that is present at 5 times or greater (ppm at 15% ABV) than the listed max use level is generally unfit for beverage purposes.

The Flavor Unfitness Worksheet will perform all the necessary calculations to determine if a flavor ingredient is 5X the max use level.

Download the Flavor Unfitness Worksheet (Excel).

The Flavor Unfitness Worksheet now includes a version number. The number will change with every update of the FUW. To ensure you have the most up to date unfitness information, the latest version should always be used. Please disregard any previous versions of this worksheet. The current version is V2023.1 uploaded December 2022.

Recent changes to the Flavor Unfitness Worksheet (V2023.1) include:

  • Added ingredients to 0.1% list
  • Changed Weight/Volume of Final Product” to “Theoretical Weight/Volume” for washed extracts, black pepper powder, and cocoa nibs
  • Added GRAS 31 chemicals (FEMA 4981 - 5012)
  • Updated use levels based on GRAS 31 updates
  • Added TTB limited ingredients to limited ingredient list
  • Added ingredients to the 1% list

Recent changes to the Flavor Unfitness Worksheet (V2022.1) include:

  • Changed various FEMA GRAS materials to ‘SEE 1% LIST,’ ‘NO GUIDELINE,’ and ‘PRIMARY GDL.’
  • Added Gum Arabic, hydrogen octenyl-butane dioate (FEMA 4227) as limited ingredient (limited per FDA GRAS Notice #247)
  • Expanded CAS number column width on GRAS Materials tab
  • Added GRAS List 29 (includes removal of ethyl nitrate - changed to ' NOT GRAS')
  • Based on GRAS List 29 - added the 'Natural Only (83 Fed. Reg. 50490. 9 October 2018)' to benzophenone (2134), ethyl acrylate (2418), myrcene (2762), pulegone (2963), and pyridine (2966).
  • Washed Extract guideline updated to include a combination of citrus oils.
  • Corrected various typos.

Not sure how to use the Flavor Unfitness Worksheet? Download instructions with examples!

FEMA GRAS™ average maximum use levels courtesy of the Flavor and Extract Manufacturers Association.

Primary Guidelines for Nonbeverage Product Formulation

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.

Click here to view ingredient list.

 

Page last reviewed: October 25, 2017
Page last updated: December 20, 2022
Maintained by: Scientific Services Division