Formula Approval and Standards of Identity
Two separate controls sit behind a label. One decides whether the product may be produced at all in the form intended. The other decides what the resulting liquid may be called, and neither is settled by the label certificate.
The rule in short
Formula approval is required before production of specified products: certain wines under 27 CFR 24.80, fermented products made by non-traditional processes or with added flavors, colors or food materials under 27 CFR 25.55, and distilled spirits specialty products under Part 5. Standards of identity in 27 CFR 4.21 and 27 CFR Part 5 subpart I define the classes and types a label may claim, and a product that does not meet a standard may not carry that designation.
Two federal controls operate on a product before anyone thinks about the label. Formula approval asks whether the product may be produced in the intended way. A standard of identity asks what the finished liquid may be called. Both are separate from the certificate that authorizes the artwork on the container.
Products that need approval before production
For wine, section 24.80 requires the proprietor to obtain approval of the formula and process before producing special natural wine, agricultural wine, and wine other than standard wine, with limited exclusions. The formula is filed on the prescribed form and must cover each ingredient and, where the process requires approval, each process used in production.
For fermented products, section 25.55 requires a formula where the product will be treated by a process not generally recognized as traditional in producing a beverage designated as beer, ale, porter, stout, lager or malt liquor. It also requires one where flavors or other nonbeverage ingredients containing alcohol are added, and, subject to the conditions in the section, where coloring, natural or artificial flavors, fruit, juice, herbs, spices, honey, maple syrup or other food materials are added.
For distilled spirits, formula requirements attach to specialty products and to products made with added flavoring or coloring materials that affect the class and type. The common thread across all three categories is that approval must precede production. A formula obtained after the batch was made does not cure the omission.
Classes, types and the words a label may use
Standards of identity are the definitions that divide products into classes, which are further divided into types. Section 5.141 explains that distilled spirits are divided this way for labeling purposes, and that a label must bear the appropriate class, type or other designation. The standards themselves then define each one: whisky, gin, brandy, rum, agave spirits, cordials and liqueurs, and the rest.
The wine standards in section 4.21 work the same way, with classes such as grape wine, sparkling grape wine and citrus wine, and with compositional limits inside each. Table wine and dessert wine are distinguished by alcohol content, and several traditional names are available only where the product meets stated conditions.
Two drafting rules matter in practice. Where a product conforms to more than one standard, it may be designated with any single class designation it qualifies for. And where both a class and a type are used, the type must be as conspicuous as the class and must appear in the same field of vision.
Standards of identity are compositional, so a modest production adjustment can change what the product may be called. Adding a flavoring material, changing the proportion of neutral spirits, or treating a wine in a way outside the authorized cellar treatments may take the product out of the class its brand name assumes. The result is not usually a prohibited product; it is a product that must be relabeled with a different designation or a statement of composition, after the packaging has been printed.
| Product | Formula trigger | Authority | Designation control |
|---|---|---|---|
| Standard grape wine | Generally none | 27 CFR Part 24 | Standards of identity in 27 CFR 4.21 |
| Special natural or agricultural wine | Formula required before production | 27 CFR 24.80 | Class and type per Part 4 |
| Traditionally produced beer | No formula required | 27 CFR 25.55 | Designation per Part 7 |
| Beer with added flavors or fruit | Formula required | 27 CFR 25.55 | Statement of composition where needed |
| Whisky, gin, rum, brandy | Generally none if unaltered | 27 CFR Part 5 | Standards in subpart I |
| Distilled spirits specialty product | Formula required | 27 CFR Part 5 | Statement of composition |
Altering class and type
Section 5.155 addresses alteration of class and type. Where a product that met a standard is treated or has material added in a way the standards do not permit for that class, the designation changes. That is the mechanism by which a flavored version of a defined spirit becomes a different labeling category rather than a variation on the original.
Specialty products absorb what is left. Where a distilled spirits product does not fit any defined class or type, it is designated by a statement of composition describing what it is made from. The statement is not a penalty; many established products sit in this category permanently and are marketed successfully.
The sequence a producer should follow
The order is formula, then designation, then label. A producer that designs packaging first, applies for a certificate, and only then discovers that the intended process required a formula has to redo the packaging as well as the filing. Where a formula was required and not obtained, the product itself was produced unlawfully, which is a heavier problem than a rejected label.
Once the designation is settled, the label requirements follow, including the mandatory statements described in the certificate of label approval and what it authorizes. Both controls sit on top of the authorization to operate at all, described in the federal basic permit requirements. Where finished product will be sold to households across state lines, the additional conditions in the rules on interstate shipping to consumers apply, and a comparable pre-market compositional review in another regulated field is described in manufacturing quality systems and how they are inspected.
Points to carry away
- A formula must be approved before production, not before bottling or labeling.
- Wine formulas cover special natural wine, agricultural wine and other than standard wine.
- A fermented product needs a formula when a non-traditional process or added flavor is used.
- Standards of identity divide products into classes and further into types.
- A product that does not meet a standard must carry a different designation.
- Altering a product after it meets a standard can change its class and type.
Questions readers ask
Which brewing processes require a formula?
The regulations divide processes into traditional and non-traditional. Pasteurization, filtration before bottling, centrifuging for clarity, lagering, carbonation and blending are given as traditional processes that need no formula. Removing water, filtering to substantially change color, flavor or character, separating beer into components, reverse osmosis, concentration and ion exchange are given as non-traditional processes that do. Adding flavors or other nonbeverage ingredients containing alcohol also triggers the requirement, and TTB will answer a request about a process the section does not list.
What happens if a product does not meet any standard of identity?
It is not unlawful; it simply cannot use a designation it does not qualify for. Distilled spirits that do not fit a defined class or type are handled as specialty products and are designated by a statement of composition rather than by a class name. The same logic runs through wine and malt beverage labeling. Producers frequently discover late that a small production choice, such as an added ingredient, moved the product out of the class the brand was built around.
How long does an approved formula last?
A wine formula approved under the regulations remains in effect until it is revoked, superseded or voluntarily surrendered, so there is no renewal cycle. What changes the position is a change to the product: a new or superseding formula is required when the composition or process departs from what was approved. Producers who adjust an ingredient supplier, a flavor concentration or a processing step should check whether the change is within the approved formula before the batch is made rather than afterward.
Sources
- eCFR — 27 CFR 24.80, Formulas for WineThe requirement to obtain formula and process approval before production of specified wines.
- eCFR — 27 CFR 25.55, Formulas for Fermented ProductsThe traditional and non-traditional process examples and the added-ingredient triggers.
- eCFR — 27 CFR 5.141, The Standards of Identity in GeneralHow classes and types work and the rules for designating a product with both.
- eCFR — 27 CFR 4.21, The Standards of Identity for WineThe classes of wine and the compositional limits attached to each designation.
- eCFR — 27 CFR 5.155, Alteration of Class and TypeWhen treatment or addition changes the class and type a product may claim.
- Alcohol and Tobacco Tax and Trade Bureau — FormulationThe agency's own material on formula submission and the products it covers.
Liberty Law Library is a publication, not a law firm. This article states general rules and cites its sources; it is not advice about any particular case, and the law differs by state and changes over time.
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