§ 25.58. New and superseding formulas.
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/us/cfr/t27/s§ 25.58·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)New formulas. Except as otherwise provided in paragraph
(b)of this section, you must file a new formula (with a new formula number) for approval by TTB if you---
(1)Create an entirely new fermented product that requires a formula;
(2)Add new ingredients to an existing formulation;
(3)Delete ingredients from an existing formulation;
(4)Change the quantity of an ingredient used from the quantity or range of usage in an approved formula;
(5)Change an approved processing, filtration, or other special method of manufacture that requires the filing of a formula; or
(6)Change the contribution of alcohol from flavors or ingredients that contain alcohol.
(b)Superseding formulas. You may file a superseding formula, instead of a new formula, if you have made any change listed in paragraphs (a)(2) through (a)(6) of this section and that change is not of a type that would require a holder of a certificate of label approval to file a new application for label approval on TTB Form 5100.31.
(1)A superseding formula replaces an existing formula, and you should file one only if you do not intend to use the existing formula any more. A superseding formula must be filed with TTB for approval. When TTB approves a superseding formula, TTB will cancel your previous formula.
(2)You may use the same formula number for a superseding formula that you used for the formula the superseding formula replaces, but you must annotate the formula number to indicate it is a superseding formula number. (For example, "Formula 2, superseding.")
(c)When you file a new or superseding formula with TTB, you must follow the procedures and other requirements of §§ 25.56 and 25.57.