Home.Obtaining Formula Approval

Alcohol and Tobacco Tax and Trade Bureau

How Do I Obtain Formula Approval?

For many alcohol beverage products, TTB must evaluate the product and approve its formula before issuing a Certificate of Label Approval (COLA) to determine whether a proposed label identifies the product in an adequate and non-misleading way. We refer to this requirement as a Pre-COLA Product Evaluation.

There are four types of pre-COLA product evaluation.  The type of pre-COLA product evaluation required for a particular product depends on that product’s formulation and origin.

TTB regulations require formulas most commonly when flavoring or coloring materials are added to an alcohol beverage product. Since TTB does not have access to foreign plants, some imported products are subject to laboratory analysis or pre-import formula approval. For further information, visit the Formulation page.

Do I Need Formula Approval for My Product?

To determine if your product requires formula approval and/or laboratory analysis, please use the drop down menus to first select your industry, and then the alcohol beverage product for which you are seeking label approval.  Please identify whether the product is domestic or imported, and then click on SHOW ME.

If a formula approval is required, please follow the instructions provided on how to obtain this approval.  If no formula approval is required, you are ready to submit your application for label approval.

  
  Domestic     Imported
 
NO FORMULA APPROVAL REQUIRED
You do not need to submit for Pre-COLA product evaluation. You may apply for label approval now.
FORMULA APPROVAL REQUIRED

Submit TTB Form to our Advertising, Labeling and Formulation Division.
LABORATORY ANALYSIS REQUIRED
Submit a 750 ml sample, along with a complete list of ingredients and method of manufacture to the .
The Laboratory receives the sample. If any additional information is needed, the lab will contact you before analyzing the sample.
The chemist analyzes the sample and mails the results to the Advertising Labeling and Formulation Division. The analysis takes 3-4 weeks.
A formula specialist verifies that all of the information has been submitted and contacts other specialists as needed to determine the GRAS (generally recognized as safe) status and the product tax classification.
After reviewing all of the information, the formula specialist will make a determination of APPROVAL or REJECTION. This step usually takes 2-3 weeks.
APPROVAL
REJECTION
You will receive the approved application with the classification of the product. You may now apply for label approval by submitting a copy of the formula approval with the label application, TTB Form . Our rejection letter will include an explanation of the information needed to process this application.

Questions?

You may direct questions on pre-COLA product evaluations and the submission of domestic and pre-import formulas to the TTB Advertising, Labeling and Formulation Division (ALFD).  An ALFD Customer Service Specialist can be reached by phone at (202) 453-2250 or (866) 927-2533 (toll free), or at alfd@ttb.gov.

We also provide printable charts for Wine, Distilled Spirits, and Malt Beverages that list the current pre-COLA product evaluation requirements for products by commodity. These charts serve as general guidance. A specific product may need pre-COLA product evaluation even though no such
requirement is indicated on the chart. Please note that a Pre-Import Formula requirement in the returned results above is the same as the Pre-Import Letter requirement shown in the printable charts.

   

 

Page last reviewed/updated: 09/04/2012

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