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Revisions to Approved Formulas
TTB understands that changes in approved formulas may occur. Use the following guidelines for the TTB number when submitting revisions of approved formulas. Changes to the approved formula should be specified in a note or comment per 27 CFR 17.122.
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).
- Substituting an intermediate (provided there is no change in color or limited ingredient).
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 you are 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.