Formula Approval with Laboratory Sample 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:

• Example wine, distilled spirits, and malt beverage formulas
• Supporting documentation

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:

• Instructions for entering sample sent date  
• Instructions for printing the Sample ID Sheet
• How to send alcohol beverage samples to the TTB laboratory

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:

• Flavor Ingredient Data (FID) Sheet
• Limited Ingredient Calculation Worksheet
• Specification Sheet

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

**Please note that all shipping and handling costs are the responsibility of the submitter/shipper. If SSD receives an invoice from your company, all submissions will be placed on hold until the invoice has been paid.**

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:

• Flavor Ingredient Data (FID) Sheet
• Limited Ingredient Calculation Worksheet
• Specification Sheet

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

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., artemesia (wormwood), tansy, yarrow)
Any distilled spirit, wine or beer/malt beverage made with a “hemp” ingredient
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
Rice wine/saké
Vermouth (Italian vermouth is exempt from formula and laboratory sample analysis)
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. Therefore, imported wine with less than 7 percent alcohol by volume and imported beers that do not contain both malted barley and hops are not generally subject to formula requirements.