Which Alcohol Beverages Require Formula Approval?

Beer and Malt Beverages

Select the origin of your product.

Domestic Imported

Is your product a Saké?

Yes No

Is the alcohol content of your Saké greater than or equal to 7% by volume?

Yes No

Does your Saké contain added flavors or coloring materials?

Yes No

Is your product a Kombucha?

Yes No

Is your product made with

Malted barley?	Yes No
Hops?	Yes No

Is your product made with hemp or a hemp component?

Yes No

Is your product made with any of these ingredients?

Extracts (other than hops extract)	Yes No
Essential oils	Yes No
Syrups	Yes No
Flavors that contain alcohol	Yes No
Natural or artificial flavors	Yes No
Compounded flavors	Yes No
Coloring	Yes No
Artificial sweeteners (for example, sucralose, saccharin, or aspartame)	Yes No
Fruit, herbs, spices, honey, maple syrup, or other food materials	Yes No
Any ingredient that typically contains thujone (for example, wormwood, tansy, or yarrow)	Yes No

Are any of the following processes used in the manufacture of your beer product?

Removal of any volume of water (for example, by freezing)	Yes No
Filtration in order to substantially change the color, flavor, or character	Yes No
Separation into different components	Yes No
Reverse osmosis (on the product itself, not on ingredients used in the product, such as water)	Yes No
Concentration (production of beer concentrate)	Yes No
Ion exchange treatments	Yes No
Any other process or treatment not listed above that significantly changes the color, flavor, or character	Yes No

Is the alcohol content of your product 0.0 percent by volume (alcohol free)?

Yes No

Is freezing or any other process used to reduce the volume of your product through the extraction of ice crystals?

Yes No

Is your product made with any ingredient other than grain, hops, water, and yeast?

Yes No

Do at least 51 percent of the fermentable materials used in production of your malt beverage consist of malted barley with or without rice, other grains, bran, glucose, sugar and/or molasses?

Yes No

Is your product made with any of these ingredients?

Extracts (other than hops extract)	Yes No
Essential oils	Yes No
Syrups	Yes No
Flavors that contain alcohol	Yes No
Artificial flavors	Yes No
Compounded flavors	Yes No
Certified colors	Yes No
Artificial sweeteners (for example, sucralose, saccharin, or aspartame)	Yes No
Any ingredient that typically contains thujone (for example, wormwood, tansy, or yarrow)	Yes No

Is your product made with hemp or a hemp component?

Yes No

Malt beverages made with certain fruits (whole, juice, puree, or concentrate), herbs, spices, and other food materials are exempt from formula approval under TTB Ruling 2015-1.

View Attachment 1 to TTB Ruling 2015-1 for a list of ingredients to determine if the fruit(s), herb(s), spice(s), and other food material(s) in your malt beverage are exempted from formula requirements.

Is your malt beverage made with any fruit, herb, spice, or other food material that DOES NOT appear on the list?

Yes No

Are any of the following processes used in the manufacture of your product?

Removal of any volume of water (for example, by freezing)	Yes No
Filtration in order to substantially change the color, flavor, or character	Yes No
Separation into different components	Yes No
Reverse osmosis (on the product itself, not on ingredients used in the product, such as water)	Yes No
Concentration (production of beer concentrate)	Yes No
Ion exchange treatments	Yes No
Any other process or treatment that significantly changes the color, flavor, or character	Yes No

Imported Saké under 7 percent alcohol by volume does NOT REQUIRE formula or label approval.

This product must comply with the food labeling requirements of the U.S. Food and Drug Administration.

Domestic Saké with added flavors or coloring materials REQUIRES formula approval.

Proceed to Formulas Online to apply and select Saké (Flavored/Colored) - Domestic from the Class/Type dropdown on the Main tab.

Domestic Saké REQUIRES formula approval.

Proceed to Formulas Online to apply and select Saké - Domestic from the dropdown on the Main tab.

Imported Saké greater than or equal to 7 percent alcohol by volume with added flavors or coloring materials REQUIRES formula approval.

Proceed to Formulas Online to apply and select Saké (Flavored/Colored) - Imported from the Class/Type dropdown on the Main tab.
Note: Imported Saké is classified as wine for labeling purposes.

Imported Saké greater than or equal to 7 percent alcohol by volume REQUIRES formula approval and laboratory sample analysis

Proceed to Formulas Online to apply and select Agricultural Wine/Sake/Rice Wine – Imported from the Class/Type dropdown on the Main tab and complete all required information on the Samples tab.
Note: Imported Saké is classified as wine for labeling purposes.

Domestic Kombucha REQUIRES formula approval.

Proceed to Formulas Online to apply and select Kombucha from the Class/Type dropdown on the Main tab.
This product does not require a TTB Certificate of Label Approval.
This product must comply with the labeling requirements in 27 CFR part 25 subpart J.
This product must also comply with the food labeling requirements of the U.S. Food and Drug Administration.”

Imported Kombucha does NOT REQUIRE formula or label approval.

This product must comply with the food labeling requirements of the U.S. Food and Drug Administration.

Imported beer made with malted barley but without hops does NOT REQUIRE formula or label approval.

This product must comply with the food labeling requirements of the U.S. Food and Drug Administration.

Imported beer made with hops but without malted barley does NOT REQUIRE formula or label approval.

This product must comply with the food labeling requirements of the U.S. Food and Drug Administration.

Imported beer made without both malted barley and hops does NOT REQUIRE formula or label approval.

This product must comply with the food labeling requirements of the U.S. Food and Drug Administration.

Beer made with hemp or a hemp component REQUIRES formula approval.

Proceed to Formulas Online to apply and select Product Excludes Malted Barley And/Or Hops from the Class/Type dropdown on the Main tab. Refer to our Hemp Policy for information on what must be included as supporting documentation with your formula application.

Domestic beer made with flavoring, coloring, and sweetening ingredients REQUIRES formula approval.

Proceed to Formulas Online to apply and select Product Excludes Malted Barley And/Or Hops from the Class/Type dropdown on the Main tab.

Domestic beer made with any ingredient that typically contains thujone REQUIRES formula approval and laboratory sample analysis.

Proceed to Formulas Online to apply and select Product Excludes Malted Barley And/Or Hops from the Class/Type dropdown on the Main tab and complete all required information on the Samples tab.

Domestic beer made with any of these processes REQUIRES formula approval.

Proceed to Formulas Online to apply and select Product Excludes Malted Barley And/Or Hops from the Class/Type dropdown on the Main tab.

It appears this domestic beer does NOT REQUIRE formula approval.

This product does not require a TTB Certificate of Label Approval.
This product must comply with the labeling requirements in 27 CFR part 25 subpart J.
This product must also comply with the food labeling requirements of the U.S. Food and Drug Administration.

Malt beverages with 0.0 percent alcohol by volume REQUIRE formula approval and laboratory sample analysis.

Proceed to Formulas Online to apply and select Alcohol Free Beer from the Class/Type dropdown on the Main tab and complete all required information on the Samples tab.

Malt beverages that are made with a process to reduce the volume through the extraction of ice crystals REQUIRE formula approval.

Proceed to Formulas Online to apply and Select Ice Beer from the Class/Type dropdown on the Main tab. See TTB Ruling 94-3 for TTB’s policy on ice beer.

Malt beverages made with less than 51 percent malted barley with or without rice, other grains, bran, glucose, sugar and/or molasses REQUIRE formula approval.

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab.

Malt beverages made with any of these ingredients REQUIRE formula approval.

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab.

Malt beverages made with any ingredient that typically contains thujone REQUIRE formula approval and laboratory sample analysis [link to new guidance].

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab and complete all required information on the Samples tab.

Domestic malt beverages made with hemp or a hemp component REQUIRE formula approval.

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab. Refer to our Hemp Policy for information on what must be included as supporting documentation with your formula application.

Imported malt beverages made with hemp or a hemp component REQUIRE formula approval and laboratory sample analysis.

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab and complete all required information on the Samples tab. Refer to our Hemp Policy for information on what must be included as supporting documentation with your formula application.

Malt beverages made with any fruit, herb, spice, or other food material that does not appear on Attachment 1 REQUIRE formula approval.

Proceed to Formulas Online to apply and select Malt Beverage Specialty from the Class/Type dropdown on the Main tab.

Malt beverages made with any of these processes REQUIRE formula approval.

Proceed to Formulas Online to apply and select Made With Non-Traditional Process(es) from the Class/Type dropdown on the Main tab.

It appears this malt beverage does not require formula approval.

See 27 CFR 7.30 (imports) and 7.40 (domestic) for information about when a Certificate of Label Approval is required.
If required, proceed to COLAs Online to apply.

Last updated: January 20, 2025