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Which Alcohol Beverages Require Formula Approval?


For certain wines, distilled spirits and beers, TTB must evaluate the ingredients and production process before the product can be made or imported, and before the bottler or importer may apply for a Certificate of Label Approval (COLA). In addition, in some cases we also conduct laboratory analyses of a sample of the product in conjunction with reviewing the formula. 

TTB regulations most commonly require formulas when flavoring or coloring materials are added to an alcohol beverage. Some imported products are also subject to pre-import formula approval and/or laboratory analysis. For further information on alcohol beverage formula requirements, visit the alcohol beverage formulas page.

Do I Need Formula Approval for My Product?

To determine if your beer/malt beverage requires formula approval or formula approval with lab sample analysis either browse a list or use this tool.

Beer/Malt Beverage

To determine if your wine or distilled spirit requires formula approval, use the tool below.

  
  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 your formula through Formulas Online.
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 sends the results to the Advertising Labeling and Formulation Division.
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.
See to for a list of ingredients and processes used in the production of beer that are not subject to formula requirements. If the ingredients and processes used in the production of your beer are not included in Attachment 1 to TTB Ruling 2015-1, submit to our Advertising, Labeling, and Formulation Division.
After reviewing all of the information, the formula specialist will make a determination of APPROVAL or REJECTION.
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 using . Our rejection letter will include an explanation of the information needed to process this application.

Related Information

We also have charts that provide the current formula requirements for all Wines, Distilled Spirits, and Malt Beverages. These charts serve as general guidance; however, TTB may require, on a case-by-case basis, information about the formulation and ingredients of any alcohol beverage at any time during the label review process or whenever necessary to enforce TTB regulations.

Formula Applicability Resources

As part of our ongoing efforts to reduce the regulatory burdens associated with formula approval, we have reviewed the formula requirements for wines, distilled spirits and malt beverages and determined where we could streamline and modernize the formula review process.  The following documents provide detailed explanations about how and why we have eliminated formula submission requirements for certain alcohol beverages:

   

Description: http://icons.iconarchive.com/icons/judge/iphone/128/phone-icon.png CONTACT US
For more information about alcohol beverage formula requirements, contact the Advertising, Labeling and Formulation Division at 202-453-2250 or toll free at 866-927-ALFD (2533), or by email at Submit an Online Inquiry.

Page last reviewed: September 27, 2012
Page last updated: November 16, 2017
Maintained by: Knowledge Management Staff

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