Does Your Wine Require Formula Approval
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has the authority to regulate the production and importation of wine in the United States. In some cases, the TTB requires approval of the formula before a manufacturer may make certain wines. The rules relating to whether a formula is required, however, can be confusing. For example, is a formula required for a wine made from both apple and raspberry? What about a dry-hopped mead? ere is a well-known joke among lawyers:
A law school professor said to a graduating class, “Three years ago, when asked a legal question, you could answer, in all honesty, ‘I don’t know.’ Now you can say with great authority, ‘It depends.”
Thus it is with wine formulas; the answer to both questions above is… it depends.
What is a Formula and Why Does It Need Approval?
In simple terms, a formula is a recipe for the wine. It tells the TTB the total yield or batch size, provides a quantitative list of ingredients, describes how the product is produced, and quantifies the alcohol content of the finish product. As the agency charged with ensuring the safety of alcoholic beverages, the TTB needs this information to ascertain any potential health threats. While wine made solely from the juice of ripe grapes (see “Natural Wines,” below) is well understood and does not require submission of a formula, manufacturers like to push the boundaries of flavor and impact, fermenting whatever they determine to be fermentable. Submitting formulas for such wines enables the TTB to determine whether those boundaries may have been pushed too far.
Types of Wine
While there are many types of wine defined in Title 27, Section 24.10 of the Code of Federal Regulations (27 CFR §24.10), for the purposes of this article, we will focus on four.
Natural Wine – “The product of the juice or must of sound, ripe grapes or other sound, ripe fruit (including berries) made with any cellar treatment authorized by … this part and containing not more than 21 percent by weight (21 degrees Brix dealcoholized wine) of total solids.”
Special Natural Wine – “A product produced from a base of natural wine… to which natural flavorings are added, and made pursuant to an approved formula in accordance with… this part.”
Agricultural Wine – “Wine made from suitable agricultural products other than the juice of grapes, berries, or other fruits.”
Other than Standard Wine – this catchall category encompasses wines that either don’t fit another category or fall outside a regular category by exceeding some defined limitation (e.g., a natural wine that contains more than 21 percent by weight of total solids).
Most wines on the market are made from ripe grapes using standard production and cellaring practices and, therefore, fall within the category of Natural Wines, which do not require the submission of a formula for approval. Natural Wines may be ameliorated, chaptalized, or sweetened and may only be fortified with wine spirits. Before or during fermentation, the following ingredients may be added: sugar or concentrated fruit juice from the same kind of fruit, yeast, yeast nutrients, malo-lactic bacteria, sterilizing agents, and water (so long as the added water does not reduce Brix below 22 degrees (SG 1.092).
A list of the specific materials used in the process of filtering, clarifying, or purifying wine and the amounts that are permitted to be used in Natural Wines is listed in 27 CFR §24.246. Use of these materials outside of the specified ranges, or use of unapproved treatment materials, may render the product an Other Than Standard Wine, requiring a formula approval, see below.
Included in Natural Wines are also products made from the fermentation of a blend of fruit juices. For example, a wine made from fermenting apple juice and raspberry juice or grape juice and cherry juice are Natural Fruit Wines and do not require a formula. However, a blend of two finished Natural Wines of different fruits (e.g., apple wine and raspberry wine) is considered an Other Than Standard Wine, requiring a formula.
Special Natural Wine
A Special Natural Wine begins with a base of Natural Wine, but is then flavored with natural herbs, spices, fruit juices, natural aromatics, natural essences, or other natural flavorings. The quantities or proportions of these additions must result in character and flavor that is distinctive from the base wine and distinguishable from other natural wine. Only 100% natural flavors may be used. Examples of Special Natural Wine include wine made from apple juice and flavored with hops or wine made from pear juice and flavored with honey. For coloring purposes, only caramel is permitted.
Interestingly, under 27 CFR §24.197, the natural flavoring materials may be added before or during fermentation. For example, one might add natural cinnamon to an apple wine during fermentation. In that case, the wine would require a formula, because it is a Natural Wine to which a natural flavor was added (i.e., a Special Natural Wine). But, if the natural flavor is itself a fermentable, like raspberry juice, then whether a formula is required depends on when the raspberry juice is added.
Fruit juice added after fermentation is a natural flavor that is acceptable for Special Natural Wine. However, fruit juice added before or during fermentation will ferment and will be considered a fermentable instead of a flavor and the product is considered a Natural Wine, not requiring a formula.
One other wrinkle arises in the context of blending Special Natural Wines. If two Special Natural Wines, each having their own previously approved formula are then blended together, it will require the approval of a formula for the blend; unless, the two Special Natural Wines are of the same type. For example, producing a sweet vermouth by blending two sweet vermouths, each produced under an approved formula, the submission and approval of an additional formula is not required. See 27 CFR §24.198.
Agricultural Wine is made from non-fruit agricultural products, such as carrots, onions, rhubarb, or dandelions. Honey wine (mead) and rice wine (sake) are also Agricultural Wines. With the exception of rice, however, fermented beverages made from grains, cereals, malts, and molasses are considered malt beverages (i.e., beer) and not Agricultural Wines.
Pure dry sugar may be added to agricultural wines provided that the weight is less than the weight of the water and the agricultural product. The Agricultural Wine may only be sweetened if the alcohol content is below 14% ABV. No added natural or artificial flavors or colors are permitted, with the exception that hops may be added to honey wine, so long as the hops do not exceed one pound per 1,000 pounds of honey.
While, as a category, Agricultural Wines require prior formula approval, the TTB has made certain exceptions. In view of the nearly 4,000 wine formula applications submitted in 2015, the TTB sought to streamline the approval process. One of these efforts resulted in the issuance of TTB Ruling 2016-2, which approved general formulas for certain “standard” agricultural wines. So long as the production guidelines set forth in 27 CFR §§24.202-204 are met, no formula is required for the following Agricultural Wines: carrot wine, dried fruit wine, honey wine (mead), maple syrup wine, onion wine, pepper wine, pumpkin wine, rhubarb wine, sweet potato wine, and tomato wine. If one of these wines is produced outside the guidelines in the regulations, however, it will be classified as “Other Than Standard Wine,” as discussed, below.
Other Than Standard Wine/Wine Specialty
More of a catch-all category, this group of wines generally falls outside the bounds of other groups either by containing ingredients not permitted in those categories or by exceeding the permissible range for one or more allowed ingredients. Specifically, wines in this category include: high fermentation wine, heavy bodied blending wine, Spanish type blending sherry, and wine products not for beverage use.
Further, wines made with sugar and/or water outside the limitations prescribed for standard wine; wine made by blending wines produced from different kinds of fruit; wines made with sugar other than pure dry sugar, liquid pure sugar, or invert sugar syrup; and wine made with materials not authorized for use in standard wine fall into this category. Distilling material and vinegar stock are also considered part of the category, but unlike the others, they do not require formula approval.
Although these wines may be produced on a bonded wine premises, they must remain segregated from standard wine. These wines must also be labeled with a statement of composition. The statement must include the source of alcohol (including any spirits added), the flavors, the colors, and artificial sweeteners. Certain ingredients, such as FD&C Yellow #5 and carmine/cochineal must be listed explicitly. For example, “carbonated apple wine with cherry brandy, artificial flavors and cochineal extract.” If different fermentables are combined before fermentation, the statement of composition will list them all followed with the word, “wine.” E.g., “Apple-grape-pineapple wine.” If different types of finished wines are combined, then the statement of composition lists them as separate wines. E.g., “A blend of apple and rhubarb wines.”
In general, a wine formula is required if flavors, colors, or artificial sweeteners are added to the wine or if the base wine is not produced according to regulatory requirements. It is important to note that once a formula is approved, if a manufacturer wants to change the recipe, through the addition or elimination of ingredients, changes in quantities used, or changes in the process of production, she must file a new formula application. After a change in formula is approved, the original formula must be surrendered to the appropriate TTB officer. See, 27 CFR §24.81
As for our questions from above, if apple and raspberry juices are combined and then fermented, the product is a Natural Fruit Wine and does not require a formula. If the apple juice is fermented and then the raspberry juice is added as a flavor, it is a Special Natural Wine, which does require a formula. And if a finished apple wine is mixed with a finished raspberry wine, it is an Other Than Standard Wine and also requires a formula. As for the dry-hopped mead, a formula is only required if the recipe exceeds one pound of hops per one thousand pounds of honey.
A Note About Cannabis
As the trend to marijuana legalization continues to grow, it seems that cannabis and alcohol are on a collision course, particularly with beer, but also with ciders, meads and other types of wine. In states where marijuana has been legalized, homebrewers have begun to experiment with adding marijuana to their products, but can commercial breweries and wineries do the same?
No. Certainly any winery that wanted to include some form of cannabis in its products would require a formula approval, because the additive would be either a natural flavor or an agricultural product. The TTB issued FAQ No. A29 on May 23, 2018, stating, “TTB will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under Federal law, including marijuana.”
Substances, such as tetrahydrocannabinols (THC), cannabidiols (CBD), or terpenes that are derived from any part of the cannabis plant that is not excluded from the Controlled Substances Act definition of marijuana are controlled substances, regardless of whether such substances are lawful under State law.
Certain portions of the cannabis plant, however, may be permitted. Specifically, hemp seed oil, sterilized hemp seeds, and non-resinous mature hemp stalks may be included in alcoholic beverages, subject to formula approval, which requires submission of certain lab analyses. The product label, however, must accurately identify the ingredient such that it is clear the ingredient is not a controlled substance. The label also may not mislead the public into believing the product contains a controlled substance or has effects similar to those of a controlled substance.
Brian Kaider is a principal of KaiderLaw, an intellectual property law firm with extensive experience in the craft beverage industry. He has represented clients from the smallest of start-up breweries to Fortune 500 corporations in the navigation of regulatory requirements, drafting and negotiating contracts, prosecuting trademark and patent applications, and complex commercial litigation.
Phone: (240) 308-8032