Formula Approval Basics for Domestic Producers and Importers of Alcohol Beverages
September 18, 2018
TTB G: 2018-10
Once you have been approved by TTB to start business, the next step is to determine whether your products require formula approval. Domestic producers or importers of wine, distilled spirits, or malt beverages/beer may be required to submit formula applications or product samples for laboratory analysis before applying for a certificate of label approval (COLA). Use our tool to determine which alcohol beverages require formula approval. If formula approval is not required, you may go straight to the label approval process.
In simple terms, a formula is the recipe for an alcohol beverage - a complete list of the ingredients used to make it and a step-by-step description of how it's made. In some cases, we also require submission of samples of the product for laboratory analysis.
We use the information found in the formula to:
- Classify the product for tax and labeling purposes.
- Ensure that the product does not contain any prohibited ingredients.
- Determine if limited ingredients are used within prescribed limitations or if they will impact labeling.
- Provide a suggested statement of composition for labeling purposes.
No. Most alcohol beverages are not subject to formula requirements. We require formula approval most commonly for products made with flavoring or coloring materials.
There are two easy ways you can determine whether your product requires either formula approval or formula approval with laboratory sample analysis:
- Use our formula tool to determine formula requirements, or
- Consult our guidance documents, which reflect the current requirements for formulas or formulas with laboratory sample analysis:
The producer of the alcohol beverages is responsible for complying with formula requirements for domestic alcohol beverages. The person who holds the TTB Importer's Basic Permit and imports the alcohol beverages is responsible for complying with formula requirements for imported alcohol beverages. However, the importer will need to obtain information from the foreign producer in order to submit the formula.
Domestic producers making products for which formulas are required must (subject to limited exceptions) file for formula approval before beginning production, and may not bottle, sell, or market a product requiring a formula until they have applied for, and received approval of, the formula for that product.
For imported products, the importer must apply and receive formula approval before applying for the Certificate of Label Approval (COLA) for that product. Both formula and label approval must be obtained before the importer can remove the product from Customs custody.
Note: Don't apply for label approval until you receive formula approval. You'll need the TTB Formula ID number when you apply for label approval, and certain label information, like the class/type statement, may be impacted by TTB's determination on the formula.The preferred way is through Formulas Online, our web-based system for drafting, submitting, and tracking formula and sample submissions for domestic and imported alcohol beverages and nonbeverage products. It offers the submitter a number of advantages, such as being able to check the status of the submission in real time and viewing your approvals online. Although TTB strongly encourages you to use the online option, you may submit paper formula applications using TTB Form 5100.51, "Formula and Process for Domestic and Imported Alcohol Beverages," or the appropriate form prescribed in the TTB regulations.
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 submit a paper application. In either case, you must ship a 750 mL sample of the product (or equivalent volume) directly to our laboratory. See Formula Approval with Laboratory Sample Analysis for detailed instructions.
In your application, you must provide the following information:
- New or superseding formula: For each formula submission, select whether you are entering a new submission or if you are seeking to supersede (update/replace) an existing approval.
- Company formula number: The company formula number is a unique identifier for your product. This consists of the applicable permit/brewer's notice number (which is automatically provided by the system), followed by a unique number that you provide. This number cannot match any other formulas entered under that permit/notice from any submitter.
- Class/type: Select the most appropriate classification for the product. You may review the definition and requirements for each class/type within Formulas Online.
- Units of Measurement: Select one of the following options for entering the measurements of the quantities listed on the formula:
- By percentage of the whole; or
- By volume/weight (for example, in liters and kilograms).
This dictates the units of measurement that you will be using when entering your list of ingredients.
- Total Yield: If you selected volume/weight as your units of measurement, you must state 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. If you have selected percentage as the unit of measurement, the total percentages of all ingredients should equal 100 percent.
- Detailed Quantitative List of Ingredients: Enter the kind and quantity of each and every material or ingredient to be used in the formulation of a batch of the product. Each ingredient must be identified as one of the five following types:
-
- finished alcohol
- fermentable ingredient
- flavor
- color
- other
The information needs to be specific-- we do 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.
- Method of Manufacture: Provide a detailed step-by-step description of how the product is made. This should indicate when each of the ingredients are added. Details such as temperature and pressure are not needed.
- Proof at Distillation (for distilled spirits products): Proof at distillation is the alcoholic strength of the spirit after distillation and prior to any addition of water. It is typically the highest alcohol content achieved before adjusting to the level needed for bottling.
- Final Alcohol Content: Provide 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 alcohol content of the class or type of the product.
You can view examples of wine, distilled spirits, and beer/malt beverage formulas to get an idea of the amount of detail we are looking for.
You may also need to submit supporting documentation with your application. See the next question for more details.For imported products, you must submit a document you obtain from the foreign manufacturer that includes all of the information listed in the answer above. Importers should use the letter from the foreign producer as the source document when filing their formula application 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 documents in English, 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 certain supporting documents in the "Docs/Links" tab in Formulas Online. For example, if you use flavors that contain alcohol, natural or artificial flavors, or compounded flavors (purchased from a flavor manufacturer) you must usually submit a Flavor Ingredient Data (FID) Sheet for each flavor and a Limited Ingredient Calculation Worksheet. We may also need a Specification Sheet for some ingredients.
You can view each form of supporting documentation in our example wine, distilled spirits, and beer/malt beverage formulas.You must provide the name of the flavor, the name of the flavor manufacturer, and the TTB/ATF number for the flavor, if applicable. Every flavor that has been reviewed by our laboratory for use in an alcohol beverage will have a TTB/ATF number. To speed up the formula review process, please acquire a FID sheet from the manufacturer for that flavor.
A Formula Specialist will review the information to verify that the product complies with applicable regulations. If you file through Formulas Online, you will receive email notification if you need to make any corrections or supply any additional information to us.
For products that require laboratory analysis, TTB chemists will perform those tests and forward the results to the Formula Specialist through Formulas Online. If we need any additional or clarifying information from you, we will contact you via email.
The approved formula will include the TTB classification of the product and any applicable labeling advice, for example a suggested statement of composition. Once you have received the approved formula, you may apply for label approval, if needed. Please note that your label may include more a specific statement of composition if it is consistent with the formula and the TTB regulations.Domestic Products:
A formula for domestic products remains in effect indefinitely unless:
- The formula is voluntarily surrendered;
- The formula is superseded; or
- The formula is canceled or revoked by TTB or by operation of law or regulation. For example, when the flavored malt beverage regulations were amended, noncompliant statements of process (formulas) were revoked by operation of regulation.
Imported Products:
Formulas and formulas with laboratory sample analysis for imported products remain in effect for 10 years from the TTB approval date, unless:
- The formula is voluntarily surrendered;
- The formula is superseded; or
- The formula is canceled or revoked by TTB or by operation of law or regulation.
In Formulas Online, the expiration date for the formula approval may be found under the "Results" tab in the section marked "Determination." If you wish to keep importing the product, you should apply for a new or superseding formula (depending on the circumstances) prior to the expiration date. You may also need to send another sample to the TTB laboratory.
Keep in mind that if you are required to obtain a new formula (instead of a superseding formula), you'll also need to apply for a new Certificate of Label Approval (COLA) for products covered by the new formula.A new formula is always required when you wish to start manufacturing or importing a product that requires formula approval under TTB regulations or policy. If the domestic or foreign manufacturer wishes to make changes to either the ingredients (e.g., adding new ingredients, removing ingredients, or changing the quantity of the ingredients) or method of manufacture for a product for which you already have an approved formula, you must obtain either a new formula or superseding formula, depending on the circumstances. In addition, importers must file for a new formula if:
- The foreign producer of the alcohol beverage changes (even if the beverage is still being made the same way with the same ingredients); or
- The country of origin for the product changes;
New formulas get a new TTB Formula ID number; superseding formulas keep the same TTB Formula ID number. A superseding formula replaces the existing formula; thus, you should not file a superseding formula if you intend to keep using the existing formula.
Formula approval and label approval are tied to, among other things, a product's classification or standard of identity under TTB regulations. Changes to the ingredients or method of manufacture that result in a change to product classification necessitate obtaining both a new formula and a new COLA. For example, assume that the formula for a product classified as "flavored whisky" indicates that it is made with a natural cherry flavor. If the manufacturer changes from using a natural cherry flavor to an artificial cherry flavor, the product is no longer entitled to be classified and labeled as a "flavored whisky" – thus, the certificate holder must apply for approval of a new formula and a new label.
Any changes to the product formulation that would require the holder of the COLA to make labeling changes that require filing for a new certificate of label approval will also require the submission of a new formula, even if the product classification remains the same. A superseding formula may not include changes to an approved formula that would require the submission of a new COLA.
Generally, you may file a superseding formula instead of a new formula when any changes made to the ingredients or manufacturing processes do not affect a product's classification or standard of identity and the changes do not to require the certificate holder to obtain a new COLA for the product. For example, if a producer wishes to change from one natural cherry flavor to another, the statement of composition is still adequate and no new COLA is required, however the producer must file a superseding formula to reflect the change of ingredients.
Importers may also file a superseding formula prior to the expiration of their existing formula within 10 years, but only if there have been no changes that would necessitate filing a new formula.Yes. It is your responsibility to use good manufacturing practices to ensure that the ingredients and production processes used to produce alcohol beverages result in the production of wholesome products suitable for human food consumption and that the ingredients, additives, and finished products comply with all applicable regulations of the U.S. Food and Drug Administration (FDA) regarding food safety. For general information, see FDA's Ingredients, Packaging, and Labeling page, and the "Other Regulatory Considerations" section on TTB's Importing Bottled Alcohol Beverages Into the United States page.