Frequently Asked Questions

TTB TD-21 – Flavored Malt Beverage and Related Regulatory Amendments

TTB TD-21

FMB1: How does TTB TD-21 impact the composition of flavored malt beverages?

A: The new regulation permits the addition of flavors and other nonbeverage materials containing alcohol to beers and malt beverages. Malt beverages that contain not more than 6% alcohol by volume may derive no more than 49% of their alcohol content from flavors and other nonbeverage materials. If a malt beverage contains more than 6% alcohol by volume, not more than 1.5% of the volume of the finished product may consist of alcohol derived from flavors and other nonbeverage ingredients containing alcohol.

FMB2: When do these new standards go into effect?

A: The final rule takes effect on January 3, 2006.

FMB3: My brewery produces a flavored malt beverage that derives over 90% of its alcohol content from added nonbeverage flavors, and only 10% of its alcohol content from fermentation at the brewery. What can we do if we want to continue to make this product on and after January 3, 2006?

A: On and after January 3, 2006, a product that does not comply with the requirements of TTB TD-21 may not be produced at a brewery, bottled at a brewery, removed from a brewery with or without payment of tax, removed from customs custody for consumption, or (in the case of products not destined for exportation), transferred to a second customs bonded warehouse. Such a product may be reformulated for production at a distilled spirits plant.

FMB4: Does the final rule apply to imported as well as domestic malt beverages?

A: Yes.

Alcohol Content Statement on Labels

FMB5: The rule requires mandatory alcohol content labeling for flavored malt beverages. My brewery produces a fruit-flavored ale that derives 0.4% of its alcohol content from an added flavor. Do we need to label this ale with an alcohol content statement?

A: Yes. The final rule requires an alcohol content statement on the label of any malt beverage that contains any alcohol derived from added flavors or other added nonbeverage ingredients (other than hop extract) containing alcohol.

FMB6: May I place the mandatory alcohol content statement on the back label?

A: No. The mandatory alcohol content statement must appear on the brand label.

FMB7: My brewery produces a malt beverage made with a hop extract that adds a very minimal amount of alcohol to the product. Do we have to label this malt beverage with an alcohol content statement?

A: As long as the malt beverage does not derive alcohol from any other added flavor or other added nonbeverage ingredient, it does not have to be labeled with an alcohol content statement.

FMB8: My brewery ships beer to 12 States, including one State that prohibits alcohol content on malt beverage labels. How do I comply with the Federal requirements as well as the State requirements?

A: Pursuant to the penultimate paragraph of the FAA Act, the labeling requirements of our Part 7 regulations apply only to the extent that State law imposes similar requirements on malt beverages sold within the State. Thus, brewers must comply with the labeling laws of the State in which the malt beverages are being sold.

FMB9: The only change that my brewery must make to the label is to add the required alcohol content statement. Are we required to file a new application for label approval, or should we simply add the alcohol content statement to the label?

A: Your company may add an alcohol content statement to the label without applying for a new certificate of label approval.

Labeling and Advertising Provisions

FMB10: What new labeling and advertising provisions have been added to the regulations?

A: Consistent with ATF Ruling 2002-2, the final rule prohibits the use of labeling or advertising statements, designs, devices, or representations that tend to create a false or misleading impression that a malt beverage contains distilled spirits or is a distilled spirits product.

FMB11: My brewery’s flavored malt beverage is labeled with a brand name that is also the brand name of a well-known distilled spirits product. Does TTB TD-21 allow this labeling practice?

A: The final rule provides that the use of a brand name of a distilled spirits product as the brand name of a malt beverage is not prohibited, provided that the overall label or advertisement does not present a misleading impression about the identity of the product.

FMB12: Does the final rule allow the use of cocktail names on FMB labels?

A: The final rule permits the use of a cocktail name as the brand name or fanciful name of a malt beverage, provided that the overall label or advertisement does not present a misleading impression about the identity of the product.

New Formula Requirements

FMB13: How have the statement of process requirements changed?

A: Current regulations require brewers to file a statement of process whenever they propose to produce and market a fermented beverage under a name other than “beer,” “ale,” “porter,” “stout,” “lager,” or “malt liquor.” Under the new regulations, brewers will be required to file formulas (instead of statements of process) under the circumstances set forth in the regulations.

FMB14: What brewing processes will trigger the formula requirement?

A: Formulas will be required whenever the brewer intends to produce a fermented product that will be treated by any processing, filtration, or other method of manufacture that is not generally recognized as a traditional process in the production of a fermented beverage designated as “beer,” “ale,” “porter,” “stout,” “lager,” or “malt liquor.”

FMB15: What are examples of non-traditional processes that require the filing of a formula?

A: Removal of any volume of water from beer; filtration of beer to substantially change the color, flavor, or character; separation of beer into different components; reverse osmosis; concentration of beer; and ion exchange treatments are examples of non-traditional processes for which brewers must file a formula.

FMB16: What are examples of traditional processes for which no formula is required?

A: Pasteurization; filtration prior to bottling; filtration in lieu of pasteurization; centrifuging for clarity; lagering; carbonation; and blending are examples of traditional processes for which brewers do not have to file a formula.

FMB17: What should I do if I’m not sure whether the process used by my brewery requires the filing of a formula?

A: The appropriate TTB officer may determine whether or not use of a process not listed in 27 CFR § 25.55(a)(1) requires you to file a formula for approval. You may obtain such a determination from TTB by mailing a written request to the Assistant Director, Advertising, Labeling and Formulation Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW, Washington, DC 20220.

FMB18: What information should be included in a request for a determination as to whether use of a process requires the filing of a formula?

A: The request must include:

• A detailed description of the proposed process;

• Evidence establishing that the proposed process is generally recognized as a traditional process in the production of a fermented beverage designated as “beer,” “ale,” “porter,” “stout,” “lager,” or “malt liquor”; and

• An explanation of the effect of the proposed process on the production of the fermented product.

FMB19: For what fermented products other than those produced through
nontraditional processes must a formula be filed?

A: In general, formulas must be filed for:

• Any fermented product to which flavors or other nonbeverage ingredients (other than hop extract) containing alcohol will be added;

• Any fermented product to which coloring or natural or artificial flavors will be added;

• Any fermented product to which fruit, fruit juice, fruit concentrate, herbs, spices, honey, maple syrup, or other food materials will be added; and

• Saké, including flavored saké and sparkling saké.

FMB20: Can I file for an exemption from the formula requirement for use of a particular coloring, flavoring, or food material?

A: Yes. TTB will grant such an exemption upon a finding that the coloring, flavoring, or food material in question is generally recognized as a traditional ingredient in the production of a fermented beverage designated as “beer,” “ale,” “porter,” “stout,” “lager,” or “malt liquor.”

FMB21: How do I file for such an exemption?

A: Your request should be sent to the Assistant Director, Advertising, Labeling and Formulation Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, N.W., Washington, DC 20220, and must include the following information:

• A description of the proposed ingredient;

• Evidence establishing that the proposed ingredient is generally recognized as a traditional ingredient in the production of a fermented beverage designated as “beer,” “ale,” “porter,” “stout,” “lager,” or “malt liquor”; and

• An explanation of the effect of the proposed ingredient in the production of a fermented product.

Filing Formulas

FMB22: What are the general requirements for filing a formula?

A: The requirements are as follows:

• The formula must be filed in writing;

• The formula must identify each brewery where the formula applies by including each brewery name, address, and registry number;

• You must serially number each formula, commencing with number “1” and continuing in numerical sequence;

• You must date and sign each formula; and

• You must file two copies of each formula with TTB.

FMB23: Where do I file a formula?

A: Your formula should be filed with the Assistant Director, Advertising, Labeling and Formulation Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Washington, DC 20220.

Formula Information

FMB24: What information must appear on each formula?

A: The following information must appear on each formula:

• You must list each separate ingredient and the specific quantity used, or a range of quantities used.

• You may include optional ingredients if they do not impact the labeling or identity of the finished product.

For fermented products containing flavorings, the following additional information must appear:

• The name of the flavor;

• The product number or TTB drawback number and approval date of the flavor;

• The name and location (city and State) of the flavor manufacturer;

• The alcohol content of the flavor; and

• The point of production at which the flavor was added (that is, before, during or after fermentation).

For formulas that include the use of flavors and other nonbeverage ingredients containing alcohol, you must explicitly indicate:

• The volume and alcohol content of the beer base;

• The maximum volumes of the flavors and other nonbeverage ingredients containing alcohol to be used;

• The alcoholic strength of the flavors and other nonbeverage ingredients containing alcohol;

• The overall alcohol contribution to the finished product provided by the addition of any flavors or other nonbeverage ingredients containing alcohol; and

• The final volume and alcohol content of the finished product.

FMB25: If I received approval for a beer base formula, should that information be included in the formula?

A: Yes. You must refer in your formula to any approved formula number that covers the production of a beer base used in producing the formula product. If the beer base was produced by another brewery of the same ownership, you must also provide the name and address or name and registry number of that brewery.

FMB26: What other requirements apply to all formulas?

A: The formula must also include a detailed description of each process used to produce the fermented beverage. The formula must state the alcohol content of the fermented product after fermentation and the alcohol content of the finished product. Finally, the appropriate TTB officer may at any time require you to file additional information regarding a fermented product, ingredients, or processes, in order to determine whether a formula should be approved or disapproved or whether the approval of a formula should be continued.

FMB27: If my formula includes flavors containing alcohol, am I required to list the alcohol contribution of individual flavors and other nonbeverage ingredients containing alcohol?

A: No. However, you must state the total alcohol contribution from these ingredients to the finished product.

New and Superseding Formulas

FMB28: When must I file a new formula (with a new formula number) for approval by TTB?

A: A new formula must be filed when you –

• Create an entirely new fermented product that requires a formula;

• Add new ingredients to an existing formulation;

• Delete ingredients from an existing formulation;

• Change the quantity of an ingredient used from the quantity or range of usage in an approved formula;

• Change an approved processing, filtration, or other special method of manufacture that requires the filing of a formula; or

• Change the contribution of alcohol from flavors or ingredients that contain alcohol.

FMB29: When may I file a superseding formula instead of a new formula?

A: You may file a superseding formula instead of a new formula if you change ingredients or processes and these changes would not require a new certificate of label approval. A superseding formula replaces an existing formula, and should be filed only if you do not intend to use the existing formula any more. A superseding formula must be filed with TTB for approval.

FMB30: How does a superseding formula affect the prior formula?

A: When TTB approves a superseding formula, we will cancel your previous formula.

FMB31: Should the superseding formula use the same formula number as the formula it replaces?

A: Yes, but you must annotate the formula number to indicate that it is a superseding formula number (For example, “Formula 2, superseding.”)

Miscellaneous Formula Questions

FMB32: Must separate formulas be filed for different products that require a formula?

A: Yes.

FMB33: May I file a formula for a beer base to be used in the production of one or more other fermented products?

A: Yes. The base must conform to the standards set forth in 27 CFR
§ 25.15.

FMB34: When must a formula be filed?

A: As a general rule, you may not produce a fermented product for which a formula is required until you have filed and received approval of a formula for that product.

FMB35: Is there an exception to the rule regarding prior approval of formulas?

A: You may, for research and development purposes (including consumer taste testing), produce a fermented product without an approved formula. However, if the product falls into the category of fermented products for which a formula is required, you may not sell or market the product until you receive approval of the formula.

FMB36: How long does my formula approval remain valid?

A: As a general rule, your approved formula remains in effect until:

• you supsersede it with a new formula;

• you voluntarily surrender the formula;

• TTB cancels or revokes the formula; or

• the formula is revoked by operation of law or regulation.

FMB37: Will statements of process that were approved prior to the effective date of TTB TD-21 remain valid on and after January 3, 2006?

A: Yes, provided that any finished product that could be made under the statement of process would be in compliance with the provisions 27 CFR part 25, as amended by TTB TD-21. You do not need to submit a new formula for approval if the product is covered by a statement of process that remains valid.