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When is a formula required?
The TTB requires a formula be filed for beverage alcohol products that use non-traditional processes or ingredients. Most commonly, your product requires a formula if it uses flavoring or added colors, but using certain vegetables, fruits, herbs, spices, or syrups may also trigger the requirement. The formula requirement specifically includes any ingredient which adds alcohol to the finished product.
Background on the Formula Requirement
In 1990s and early 2000s, the Bureau of Alcohol, Tobacco and Firearms (ATF) and later the Alcohol and Tobacco Tax and Trade Bureau (TTB), saw a dramatic increase in flavored malt beverages (FMBs) coming to the market. An ATF study of FMBs and found that a significant majority — 99 of 114 products evaluated—derived more than 50% of their alcohol content from flavors and distilled spirits.
After a lengthy rule-making process, the TTB created set of rules dictating how much alcohol could be contributed from non-malt ingredients. They also decided that any product using non-traditional processes or ingredients, or which had any non-malt based alcohol contribution, must file a formula listing those ingredients and the alcohol contributed by them.
Malt beverages are regulated by the 1935 Federal Alcohol Administration Act, which had contemplated only ale, lager, porter, and similar products being made by breweries.
In 2005, the TTB issued final rule TD-21 modifying the regulations around FMBs, eliminating the old “statement of process” for brewers, and creating the new formula requirement.
Additional Exempt Ingredients
At the request of industry members and trade groups, the TTB has developed a list of additional ingredients (besides malt, hops, yeast and water) which are exempted from the formula requirement. The current list of exempt ingredients was set in 2015 by the TTB. Using any ingredient not on this list will require a formula to be filed with and approved by the TTB.
The list includes a disclaimer for most of the exempt ingredients: “Does not include extracts, essential oils, or syrups.” The TTB has been careful to include this language, as extracts specifically are likely to include distilled alcohol as the flavor carrier.
Consider vanilla extract. While generally recognized as safe by the FDA, it is extracted from vanilla beans with alcohol. Using vanilla extract at any level will, technically, add non-malt alcohol to the finished product, and thus requires a formula under the 2005 ruling. In contrast, using whole vanilla beans as an ingredient would NOT require a formula, as the beans themselves are traditional, listed on the 2015 ruling, and do not contribute any alcohol to the product.
Non-Traditional Processes
The formula requirement extends to any product which uses a “non-traditional process” during production. The TTB has extended the traditional designation to many modern processes used in beer production, including centrifuging, filtration, and pasteurization. Aging in barrels or with wood staves, chips, etc. are also defined as traditional.
Of interest to seltzer producers, filtration to “substantially change the color, flavor, or character” of beer is considered a non-traditional process. As a seltzer base is brewed and fermented like a beer, it is considered a beer product by the TTB. Seltzer base is aggressively filtered after fermentation to make it clear, colorless, and as flavorless as possible, before it is blended into a finished product. Therefore, hard seltzer products, even if they are only flavored with exempt ingredients, will still require a formula to be filed with the TTB.
The products in the ATF study mentioned above almost universally processed their malt alcohol base to remove any characteristics (color, flavor, aroma, etc.) that were associated with beer and malt liquor.
While the TTB found this to be allowable, it was considered to be non-traditional.
At The Nations, one of our first steps in any project is to conduct an internal evaluation of your formula and label. If we identify potential issues, then we will work with your and your formulation consultant to address and resolve those items, to ensure a smooth and quick approval process with the TTB. This article and any feedback during your project are guidance based on our research experience with TTB formula and label approval, but they are not a substitute for advice from an attorney familiar with your state and Federal alcohol regulations.