How to Apply for Formula Approval with Lab Analysis Using Formulas Online
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:
- Instructions for entering sample sent date
- Instructions for printing the Sample ID Sheet
- How to send alcohol beverage samples to the TTB laboratory
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:
- Alcohol Beverage Formula Approval with Lab Sample Analysis
- How to Apply for Formula Approval with Lab Analysis Using Formula Online
- How to Send Alcohol Beverage Samples to the TTB Laboratory
- How to Apply for Formula Approval with Lab Analysis: Paper Alternative