October 6, 2017 TTB Seal TTB G: 2017-5  

 

TTB Public Guidance

   

Formula Approval with Laboratory Sample Analysis

Certain alcohol beverages require TTB formula approval with laboratory sample analysis before they may be produced or imported and before the domestic producer or U.S. importer may apply for label approval. View the list of alcohol beverages that require formula approval with laboratory sample analysis or use our formula approval tool to see which alcohol beverages require formula approval or lab analysis.

Key Topics

How to Apply for Formula Approval with Lab Analysis

If the product requires laboratory analysis, you may submit your sample in one of two ways. The preferred way is for the domestic alcohol beverage producer (winery, distiller, or brewer) or the U.S. importer to use Formulas Online to apply for formula approval for products that require laboratory sample analysis. Formulas Online is a web-based application that supports the online submission of applications and offers the submitter a number of advantages, such as being able to check the status of the submission in real time and viewing your approval letters. Although TTB strongly encourages you to use the online option, a paper alternative is also available.

Once logged into Formulas Online, under the "Formula" tab you must enter the required information about the alcohol beverage, including each ingredient used to make the product and a step-by-step description of how it is made, also known as the method of manufacture. Importers should obtain this information from the foreign producer. For more information view:

Then, you will need to log your sample under the "Samples" tab and print a Sample ID Sheet, which must be sent to the TTB laboratory with a 750 mL sample of the product (or equivalent volume). For more information view:

Supporting Documentation

For all imported products, the U.S. importer must upload in the "Docs/Links" tab or the "Formula" tab (in section 4 - Method of Manufacture) a document obtained from the foreign manufacturer that includes the following information:

  • Product Name: What the product is called. 
  • Detailed Quantitative List of Ingredients: Lists the kind and quantity of each and every material or ingredient to be used in the formulation of a batch of the product. The information needs to be specific-- TTB does not accept generic descriptions for ingredients such as "herbs." The list of ingredients must, among other things, include all sources of alcohol, herbs added, coloring materials, natural and artificial flavoring materials, natural and artificial sweeteners, etc.
  • Total Yield: States the quantity of product made per batch. It may be the amount of an actual batch, such as "100 gallons," or a hypothetical number that accurately represents the quantity of ingredients per yield.  
  • Method of Manufacture: A detailed step-by-step description of how the product is made.
  • Proof at Distillation (for distilled spirits products): Proof at distillation represents the alcoholic strength of the spirit after the distillation process and prior to any addition of water. It is typically the highest alcohol content achieved before adjusting to the level needed for bottling.
  • Agricultural (Botanical) Source of Alcohol:  State the ingredients from which the alcohol was fermented (for example: rye, potato, coconut, or beet sugar). "Ethanol" or "alcohol" should not be listed as the source material.
  • Final Alcohol Content: The percentage of alcohol by volume of the finished product.  This may be stated as a range, as long as the range does not cross maximum or minimum requirements for the tax rate or class or type of product. 

Importers should use this documentation from the foreign producer as the source document when filling out the "Formula" tab in Formulas Online.  All of the information on this document must be in English and must appear on the producer's company letterhead stationery. If you are unable to provide English copies, you must submit a certified English translation.

For imported and domestic products, depending on the ingredients used to manufacture the alcohol beverage, you may be required to upload the following supporting documents in the "Docs/Links" tab:

How to Send Alcohol Beverage Samples to the TTB Laboratory

Federal law prohibits sending alcohol beverages through the mail, either domestically or internationally (18 U.S.C. 1716(f)). Instead, use a common carrier or courier service when shipping your sample to the lab and follow that carrier's posted guidelines regarding the shipment of alcohol.

Send a total volume of at least 750 mL for each product together with the Sample ID Sheet to:

National Laboratory Center
Beverage Alcohol Laboratory
6000 Ammendale Road
Beltsville, MD 20705

Paper Alternative: Applying for Formula Approval with Lab Analysis

The best way to apply for formula approval with laboratory sample analysis is by using Formulas Online. Although TTB strongly encourages you to use the online option, you may instead ship the paperwork and a 750 mL sample of the product (or equivalent volume) directly to our laboratory.

Domestic alcohol beverage producers (wineries, distillers, brewers) and U.S. importers should prepare and submit TTB Form 5100.51, Formula and Process for Domestic and Imported Alcohol Beverages, containing all the required information about the product. You will also need to send supporting documentation as described below.

Supporting Documentation

For all imported products, the U.S. importer must also send a document obtained from the foreign manufacturer that includes the following information:

  • Product Name: What the product is called. 
  • Detailed Quantitative List of Ingredients: Lists the kind and quantity of each and every material or ingredient to be used in the formulation of a batch of the product.  The information needs to be specific-- TTB does not accept generic descriptions for ingredients such as "herbs." The list of ingredients must, among other things, include all sources of alcohol, herbs added, coloring materials, natural and artificial flavoring materials, natural and artificial sweeteners, etc.
  • Total Yield: States the quantity of product made per batch. It may be the amount of an actual batch, such as "100 gallons," or a hypothetical number that accurately represents the quantity of ingredients per yield.  
  • Method of Manufacture: A detailed step-by-step description of how the product is made.
  • Proof at Distillation (for distilled spirits products). Proof at distillation represents the alcoholic strength of the spirit after the distillation process and prior to any addition of water. It is typically the highest alcohol content achieved before adjusting to the level needed for bottling.
  • Agricultural (Botanical) Source of Alcohol:  State the ingredients from which the alcohol was fermented (for example: rye, potato, coconut, or beet sugar). "Ethanol" or "alcohol" should not be listed as the source material.
  • Final Alcohol Content: The percentage of alcohol by volume of the finished product. This may be stated as a range, as long as the range does not cross maximum or minimum requirements for the tax rate or class or type of product. 

All of the information on this document must be in English and must appear on the producer's company letterhead stationery. If you are unable to provide English copies, you must submit a certified English translation.

For imported and domestic products, depending on the ingredients used to manufacture the alcohol beverage, you may be required to send the following supporting documents with your sample:

See also How to Send Alcohol Beverage Samples to the TTB Laboratory

List of Alcohol Beverages that Require Formula Approval with Lab Analysis

The following alcohol beverages require formula approval with laboratory sample analysis.

Please note that TTB requires laboratory analysis without formula approval for certain other products that are not listed in this chart, and TTB may request samples of any alcohol beverage on a case-by-case basis.

Alcohol Beverages that Require Formula Approval with Laboratory Sample Analysis

All Commodities

Domestic

Imported*

Any distilled spirit, wine or beer/malt beverage made with any ingredient that typically contains thujone (e.g., wormwood, tansy, yarrow)

Any distilled spirit, wine or beer/malt beverage made with hemp or a hemp component

 

Distilled Spirits

Domestic

Imported

Blended applejack

 

Brandy (following types only)
Applejack
Dried fruit brandy (e.g., raisin wine)
Fruit (other than grape) brandy
Lees brandy
Marc brandy
Neutral brandy
Pomace brandy
Residue brandy
Substandard brandy
Grappa
Kirschwasser
Slivovitz

 

Flavored (Class 9) products
Flavored brandy
Flavored gin
Flavored rum
Flavored vodka
Flavored whisky

 

Imitation distilled spirits

 

Powdered distilled spirits

 

Whisky (the following types only)
Blended corn whisky
Blended malt whisky
Blended rye whisky
Blended rye malt whisky
Blended wheat whisky
Blended whisky
Spirit whisky

 

Wine

Domestic

Imported*

Aperitif wine

 

Asian plum wine

 

Imitation wine

 

Rice wine/saké

 

Vermouth (except Italian vermouth)

 

Beer/Malt Beverages

Domestic

Imported*

Alcohol-free malt beverages

 

*Formula requirements for imported products generally apply only if the product is classified as a malt beverage, wine or distilled spirit under the FAA Act and requires a COLA.

 

 

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Questions? For more information about alcohol beverage formulas, contact us at 202-453-2250 or toll free at 866-927-ALFD (2533), or send us a message using our Alcohol Labeling and Formulation Division (ALFD) Contact Form.

For questions about submitting samples to the TTB lab, contact us using our Scientific Services Division Contact Form.

Page last updated: October 6, 2017
Page last updated: April 27, 2018
Maintained by: Alcohol Labeling and Formulation Division

TTB G: 2017-5
OPR: ALFD
October 6, 2017