COLA and formula approval are distinct TTB requirements that apply at different stages of bringing an alcohol product to market. Understanding the difference — and knowing which applies to your product — is essential for avoiding delays.
Overview
COLA (Certificate of Label Approval) is approval of the label: the artwork, text, and mandatory statements on your packaging. Almost every alcohol product sold across state lines or imported into the US requires one.
Formula approval is approval of the recipe: the ingredients and production methods used to make the product. Only certain product categories require this, primarily those with added flavors, colors, or non-traditional ingredients.
Formula approval concerns what's in the bottle. COLA concerns what's on the bottle.
Which products require formula approval?
Formula approval is required when the TTB needs to verify that ingredients and production methods meet federal standards. Generally, products with added flavors, colors, or non-standard ingredients require formula review.
Distilled spirits
Require formula approval:
- Flavored vodkas, whiskeys, rums, and other flavored spirits
- Liqueurs and cordials
- Distilled spirits specialties
- Absinthe (also requires lab analysis for thujone content)
- Imported vodka (TTB verifies it meets the 80-proof minimum with no additives)
- Ready-to-drink cocktails
Do not require formula approval:
- Bourbon whiskey
- Straight whiskeys (rye, corn, wheat, malt)
- Scotch whisky, Irish whiskey
- Tequila, mezcal
- Cognac and other grape brandies
- Domestic vodka (unless additives beyond water are included)
Products with strict, well-defined standards of identity are exempt from formula review. When producing bourbon according to the legal definition, the TTB already knows what the product contains.
Wine
Require formula approval:
- Wines with added flavors or colors
- Wine specialties
- Imported sake (requires both formula approval and lab analysis)
- Fruit wines with non-traditional additives
Do not require formula approval:
- Standard grape wines (table wine, sparkling wine)
- Traditional fruit wines
- Most domestic wines made with standard winemaking practices
Beer and malt beverages
Require formula approval:
- Flavored malt beverages (including flavored hard seltzers)
- Beer made with hemp or hemp-derived ingredients
- Kombucha
- Malt beverages with 0.0% ABV (requires lab analysis)
- Beer with ingredients containing thujone
- Products using non-traditional processes such as ion exchange treatments
Do not require formula approval:
- Traditional beer, ale, porter, stout, lager
- IPAs, pilsners, wheat beers, and other standard styles
- Beer with traditional flavorings (whole vanilla beans may be exempt)
Sequence: formula approval before COLA
When a product requires both approvals, the formula must be approved first. COLA applications submitted without an approved formula will be rejected. This sequencing requirement can add weeks to launch timelines if not accounted for.
The required sequence:
- Submit formula application through TTB's Formulas Online
- Receive formula approval (processing time varies from days to weeks)
- Submit COLA application through COLAs Online, referencing the approved formula
- Receive COLA approval
- Product may be sold across state lines or released from Customs
For imported products, both approvals must be obtained before the product can be released from Customs custody. Factor this into import timelines.
Common misconceptions
"I only need a COLA"
This depends on the product category. If your product falls into any formula-required category, the COLA application will be rejected until the formula is approved. Use TTB's online formula determination tools to verify requirements.
"Formula approval is only for specialty products"
Flavored vodka is one of the best-selling spirits categories in the United States. Every flavored vodka required formula approval. Hard seltzers, RTD cocktails, and flavored whiskeys all require formulas. These are mainstream product categories.
"I can reuse my formula for different labels"
This is partially correct. Formula approval applies to the recipe and process, not the label. However, if formula changes affect product classification, both a new formula approval and a new COLA are required.
"Domestic products don't need formula approval"
This is incorrect. Domestic and imported products follow similar rules. The difference is that some imported products (such as sake and vodka) require additional lab analysis that domestic versions may not need.
TTB formula determination tools
The TTB provides free online tools to determine whether a product requires formula approval:
- Distilled Spirits Formula Tool
- Malt Beverage Formula Tool
- Wine/Cider Formula Tool
These are the authoritative source and are updated regularly. Consult them before submitting applications.
Relevance to COLA data
COLA Cloud focuses on label approvals, not formulas. However, understanding the relationship provides useful context when analyzing the data:
- Products with "specialty" in the class/type typically required formula approval
- Flavored variants of standard spirits had formulas reviewed before COLA submission
- COLA records show the final approved label; formula approval occurred earlier in the process
When conducting competitive analysis on flavored spirits or malt beverages, those products went through both approval processes. This context is relevant for planning your own product launches.
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