The Alcohol and Tobacco Tax and Trade Bureau’s list of approved ingredients for beer, wine, and distilled spirits works in three tiers: ingredients you can use freely without filing a formula, ingredients you can use only within concentration limits, and ingredients that are prohibited outright. Where a given ingredient falls determines whether you go straight to label approval or have to secure a formula first.
Ingredients You Can Use Without Formula Approval
The TTB recognizes that many ingredients have been part of alcoholic beverage production long enough to raise no classification or safety questions. For beer, TTB Ruling 2015-1 sets out the exempt list, and Industry Circular 2024-2 added 24 more ingredients in late 2024 after the bureau reviewed years of formula submission data and identified ingredients that appeared frequently enough to qualify as traditional.1Alcohol and Tobacco Tax and Trade Bureau. TTB Industry Circular 2024-2 – Expansion of List of Ingredients Used in the Production of Beer Exempt from Formula Requirements
The exempt list covers whole fruits, common spices, sugars, and herbs in their basic forms. Apples, blueberries, ginger, cinnamon, honey, and dozens of others appear on it. One caveat runs through the entire list: the exemption covers the whole, juice, puree, or concentrate form of each ingredient. Extracts, essential oils, and syrups made from those same plants are not exempt and will still trigger a formula requirement.2Alcohol and Tobacco Tax and Trade Bureau. TTB Ruling 2015-1, Attachment 1
Certain production methods are exempt too. For beer, these include pasteurization, filtration before bottling, filtration in place of pasteurization, centrifuging for clarity, lagering, carbonation, and blending.3Alcohol and Tobacco Tax and Trade Bureau. Ingredients and Processes Exempt from Formula Requirements for Malt Beverages A production line that only uses these standard steps with traditional ingredients doesn’t need a formula on file.
Wine producers working with standard grapes and common cellar treatments like filtering and clarifying agents can generally proceed without formula approval, as long as the materials don’t change the wine’s fundamental character in ways inconsistent with standard commercial practice. Distilled spirits producers making straight, unmodified products from traditional grains or fruits are in the same position, provided they aren’t adding flavoring, coloring, or blending across classes. A straight bourbon aged in new charred oak barrels doesn’t need a formula. A flavored vodka does.
Even when every ingredient is exempt, the TTB keeps the authority to request information about a product’s formulation on a case-by-case basis during label review or for enforcement purposes.
Ingredients Allowed Only Within Quantity Limits
Some ingredients are permitted, but only up to a defined concentration. The TTB maintains a list of flavoring substances and adjuvants subject to limitation, cross-referencing FDA regulations under 21 CFR 172.510 and related provisions.4Alcohol and Tobacco Tax and Trade Bureau. Flavoring Substances and Adjuvants Subject to Limitation or Restriction
Wormwood (Artemisia) is the most familiar example. Products containing wormwood-derived ingredients must be “thujone-free” as the FDA defines the term, which the TTB reads as containing less than 10 parts per million of thujone in the finished product. This is what allows modern absinthe to exist on U.S. shelves.5Alcohol and Tobacco Tax and Trade Bureau. Industry Circular 2007-5 – Use of the Term Absinthe for Distilled Spirits
Four artificial flavor materials get their own set of ceilings. The TTB allows vanillin up to 40 ppm, ethyl vanillin up to 16 ppm, maltol up to 250 ppm, and ethyl maltol up to 100 ppm without requiring the product to carry an “imitation” label. Exceed those limits and the labeling changes. When vanillin and ethyl vanillin appear together, the combined amount is calculated as vanillin, with ethyl vanillin multiplied by 2.5 and added to the vanillin level. The same combined-use calculation applies when maltol and ethyl maltol are used together.6Alcohol and Tobacco Tax and Trade Bureau. Limited Ingredients
Prohibited Ingredients
Some ingredients are flatly banned. Coumarin, a compound found naturally in tonka beans, cannot be added to any food product, including alcoholic beverages. The FDA has considered any food containing added coumarin to be adulterated since 1954.7eCFR. 21 CFR 189.130 – Coumarin This is a hard prohibition, not a dosage limit.
Finished alcoholic beverages also cannot contain any controlled substance.
Hemp and CBD
Hemp-derived ingredients are a frequent source of confusion. The TTB will not approve formulas containing CBD (cannabidiol) or marijuana, aligning with the FDA’s position that CBD is not a permitted food ingredient under federal law.8Alcohol and Tobacco Tax and Trade Bureau. Hemp Policy
Hemp seeds and hemp seed oil are a different story. They can be used in approved formulas, but the TTB imposes strict testing requirements. Producers must submit lab analyses of the hemp component showing the amount of THC detected, or confirming that none was detected, along with a detailed description of the testing method. Those test results must be maintained on the premises for inspection each time the hemp component is used.8Alcohol and Tobacco Tax and Trade Bureau. Hemp Policy
Labeling rules add another layer. You cannot use the word “hemp” on a label except in an approved statement of composition that describes the actual ingredient, such as “ale brewed with hemp seeds.” Imagery, slang, or design that implies marijuana, controlled substances, or psychoactive effects is prohibited.8Alcohol and Tobacco Tax and Trade Bureau. Hemp Policy
Color Additives
Adding color to an alcoholic beverage triggers formula approval requirements. Three color additives carry additional mandatory labeling obligations for malt beverages: FD&C Yellow No. 5, cochineal extract, and carmine. If any of these appears in the product, the label must specifically name the additive with a “Contains [name]” statement. Generic phrases like “certified color” or “artificial color” are not sufficient on their own for these three.9Alcohol and Tobacco Tax and Trade Bureau. Malt Beverage Labeling – Color Additive Disclosures
When an Ingredient Pushes You Into Formula Approval Territory
Even ingredients that are perfectly legal to use can trigger a formula requirement based on how they are used and in what product. Knowing the trigger for each product category tells you whether you need to file Form 5100.51 before production.
For beer and malt beverages, you need formula approval before producing any fermented product that includes coloring, natural or artificial flavors, fruit, fruit juice, herbs, spices, honey, maple syrup, or other food materials beyond what the TTB has specifically exempted. Approval is also required if your product contains flavoring or non-beverage ingredients that include alcohol, such as hop extract with an alcohol carrier.10eCFR. 27 CFR 25.55 – Formula Requirements
For distilled spirits, an approved formula is required whenever you blend, mix, compound, or treat spirits in a way that changes the class or type of the product. Adding flavoring, coloring, or sweetening to a base spirit is the most common trigger.11eCFR. 27 CFR 5.192 – Formula Requirements
For wine, formula requirements kick in when producers add non-standard materials that go beyond traditional cellar treatments. Formula wine, which includes products made with added flavoring, coloring, or high-proof spirits, always requires approval.
The TTB offers interactive tools on its website that help producers determine whether a specific product needs a formula. If no formula is required, you can go straight to applying for a Certificate of Label Approval. If a formula is required, that approval has to be in hand before you submit the label application or produce any of the product.12Alcohol and Tobacco Tax and Trade Bureau. Formulation – Alcohol Beverage Formula Approval
One practical note if you’re sourcing flavors from a supplier: when a formula relies on a compounded flavor, the manufacturer provides a Flavor Ingredient Data Sheet that discloses which limited ingredients are present, whether the flavor contains color additives, and whether any components would affect the beverage’s labeling requirements. Suppliers don’t share full proprietary formulas, but the FIDS gives the TTB what it needs to evaluate the finished product against the limits described above.13Alcohol and Tobacco Tax and Trade Bureau. FID Sheet – Guidance and Examples