If you’re in the alcohol industry, you’ve probably heard the terms TTB Formula Approval and Certificate of Label Approval (“COLA”). Both are essential compliance steps for many products, but they serve very different purposes. Understanding the distinction—and knowing when you need one, the other, or both—can save you time, money, and headaches when launching a new product.
What is a TTB Formula Approval?
A formula approval is required when the TTB needs to review the ingredients and production process of your product before it can be produced or sold.
This step is especially common for:
- Flavored malt beverages
- Cordials and liqueurs
- Ready-to-drink (“RTD”) cocktails
- Distilled Spirits Specialties (“DSS”)
- Flavored spirits (such as flavored rum or flavored vodka)
- Wines with added flavors, colors, or sweeteners
- Spirits made with nonstandard ingredients
The TTB uses the formula review to:
- Ensure your ingredients are permitted by law;
- Verify proper classification (beer, wine, or spirits); and
- Confirm labeling requirements (e.g., flavor statements, colors, allergens)
A helpful tip is to think of a formula as the recipe review stage. Similar to a recipe for a pie, a formula application will include a list of ingredients, ingredient use rates, batch size (or yield), and a short description of how the product is made.
What is a Certificate of Label Approval (“COLA”)?
A COLA is the TTB’s approval of your label. Before you can sell an alcohol product in interstate commerce (i.e., across state lines) or before an alcohol beverage can be imported into the U.S., a COLA must be obtained to ensure the label meets federal requirements.
COLA approval focuses on:
- Mandatory label information (brand name, class/type, ABV, government warning, net contents, etc.)
- Proper use of geographic indications (like “Napa Valley” or “Champagne” or similar)
- Ensuring prohibited or misleading statements are not present
- Legibility and placement of required text
A helpful tip is to think of a COLA as a governmental review of the artwork that will be physically placed on your alcohol product’s container.
When Do You Need Both?
Not all alcohol products require both a formula and a COLA—but many do. Here’s how it breaks down:
- Formula Only: It is generally rare that a product will only have a formula. However, this may occur if a company is creating a bulk product that will not be sold at retail, which may be transferred to a third party or used as one of the ingredients in a final product. Other examples include beers brewed from sugar (i.e., some hard seltzers) whose labeling generally falls subject to the regulatory authority of the Food and Drug Administration (“FDA”).
- COLA Only: Standard wines (grape wines without added flavors/colors), straight spirits (like bourbon whiskey, vodka, or Tequila without flavoring), and traditional beers (e.g., IPAs, lagers, stouts, etc.) often need only a COLA.
- Formula + COLA: If your product contains added flavors, colors, or nontraditional ingredients (e.g., a cucumber vodka, hard seltzer with natural flavors, or a coffee-infused wine), then it generally will need both. First, the TTB reviews the product’s formula. Once approved, a COLA can be submitted to TTB.
The Order of Operations
If your product requires both a formula and a label, the formula comes first. Without it, your COLA application will be rejected. Once the formula is approved, you can submit the corresponding label for review.
Make sure to build extra time into your launch timeline. Formula approvals can take a few days and up to a couple of weeks, depending on complexity and TTB processing times.
TTB formula approval and COLA serve distinct but complementary purposes. Formulas ensure your product’s ingredients and production process comply with federal law, while COLAs confirm your label meets mandatory requirements. Some products require both, with formula approval submitted first. Understanding these steps—and working with experienced counsel—can help prevent delays, reduce compliance risks, and streamline your product launch.
Navigating these requirements can be tricky, especially if you’re producing flavored, infused, or specialty alcohol products. Working with experienced alcohol counsel ensures you know which approvals you need and helps you streamline the process. Reach out to Lindsey Zahn P.C. to schedule an initial consultation to learn more about how our firm can help submit your formula and label applications.
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