The short answer
Vanilla extract is one of the few flavors with a U.S. standard of identity (21 CFR 169.175). To be called “vanilla extract” it must be a solution in ethyl alcohol of at least 35% by volume, made from vanilla beans, with at least one unit of vanilla constituent per gallon — one unit being 13.35 ounces of vanilla beans (at 25% moisture). Under 35% alcohol, the product is “vanilla flavoring”.
Other extracts and flavors are not standardized, but they still need accurate names, ingredient lists, and only permitted flavor ingredients.
Vanilla names at a glance
| Name | Alcohol | Vanilla content | Rule |
|---|---|---|---|
| Vanilla extract | 35% or more | At least 1 unit per gallon | 21 CFR 169.175 |
| Concentrated vanilla extract (“2-fold”, “3-fold”…) | 35% or more | 2 or more units; name states the fold | 21 CFR 169.176 |
| Vanilla flavoring | Under 35% | At least 1 unit per gallon | 21 CFR 169.177 |
| Concentrated vanilla flavoring | Under 35% | 2 or more units | 21 CFR 169.178 |
Extracts may contain glycerin, propylene glycol (quantity stated), sugars, dextrose or corn syrup. A product made by diluting oleoresin or concentrate must say “Made from ___” or “Made in part from ___”. Anything else added means it no longer meets the standard and is treated like any other flavor.
Other flavors and extracts
- Names: a flavor that comes only from the named source can be called “lemon extract” or “natural lemon flavor”; if it comes from other sources, words like “flavored” or “artificial” may be needed.
- Ingredient list: in a finished food, flavors may be declared as “natural flavor” or “artificial flavor” — but MSG and protein hydrolysates must be named. See special label declarations.
- Alcohol: high-alcohol extracts are also of interest to the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB), which has its own formula and tax rules for some flavor products.
- Allergens: nut extracts (almond, hazelnut) must declare the tree nut.
Example: vanilla from Madagascar and Mexico
A Madagascar processor exports pure vanilla extract at 35% alcohol and 1 unit per gallon, labeled “Pure Vanilla Extract — ingredients: vanilla bean extractives in water, alcohol (35%)”. A Mexican company makes a 2-fold extract labeled “Vanilla Extract, 2-Fold”. A third product, sweetened with sugar and at 25% alcohol, is labeled “Vanilla Flavoring”, not extract.
Basic food label review (ingredient list, allergens, net quantity) $250. FDA food facility registration with U.S. Agent from $300. Prior Notice $15 per shipment.
Frequently asked questions
How much alcohol must vanilla extract contain?
At least 35% ethyl alcohol by volume. Below that, it is vanilla flavoring.
How many vanilla beans are in one unit?
One unit of vanilla constituent is 13.35 ounces of vanilla beans (at 25% moisture) per gallon.
Can I add vanillin to vanilla extract?
No. Adding ingredients outside the standard means it can no longer be called vanilla extract.
Is “natural flavor” defined?
Yes, FDA defines natural flavor in 21 CFR 101.22 as flavor derived from natural sources such as spices, fruit, vegetables, herbs or other plant or animal material, whose main function is flavoring rather than nutrition.
Sources
- 21 CFR 169.175 — Vanilla extract
- TTB — Vanilla extract and flavor standards (21 CFR 169.175–169.181, unit of 13.35 oz)
- 21 CFR 101.22 — Flavor and color declarations
Rules checked on November 12, 2026. This article is general information, not legal advice.