What is Natural Coloring in the U.S.A.?

The Food and Drug Administration (FDA) is responsible for regulating the use of all color additives in the United States. The FDA defines two types of color additives: (1) Color Additives Subject to Certification (“certifiable”) and (2) Color Additives Exempt from Certification (“exempt”). The certifiable color additives are man-made and listed in the Code of Federal Regulations (CFR) Title 21 Part 74. They include FD&C Red # 40, FD&C Yellow # 5, FD&C Blue # 1, etc. These certifiable color additives require certification by the manufacturer and FDA to assure the safety, quality, consistency and strength of each batch. Certified color additives are commonly known as ‘artificial’ or ’synthetic’. In contrast, exempt color additives identified in 21 CFR 73 [such as annatto extract, turmeric, elderberry juice (fruit juice), red cabbage juice (vegetable juice), and caramel] do not require batch certification as the FDA has already issued one-time premarket approvals through a color additive petition (CAP) process.

With the exception of “natural flavor”, the FDA does not presently define use of the word “natural”. For example, an ingredient statement might read: “water, sugar, orange juice concentrate, natural flavors, annatto extract (color), sodium benzoate”. This example illustrates an important difference between natural flavors and exempt coloring as the FDA permits use of the word “natural” in an ingredient list to modify a flavor additive but the FDA does not permit the word “natural” to modify a color additive. It is the position of the FDA that “natural color” may imply the additive is a naturally occurring constituent inside the food. To exemplify the distinction between naturally and artificially colored foods, elderberry juice used to color elderberry ice cream illustrates an occasion when elderberry juice may be classified as a natural coloring since the elderberry juice is a naturally occurring constituent inside this food. In contrast, red cabbage juice is not a naturally occurring constituent inside elderbberry ice cream; therefore, red cabbage juice would be considered an artificial color additive in the ice cream. Since it is unusual to supplement the color of a food with an existing constituent of the food, the FDA states that all added coloring results in an artificially colored food and objects to the declaration of any added coloring as “natural” in the Ingredient Statement. Nonetheless, the food industry considers the exempt color additives to be ‘natural colors’ in the informal sense because they are derived from natural sources.

The FDA has set forth multiple examples of how to declare color additives exempt from certification on an ingredient statement including (1) “colored with annatto extract”, (2) “annatto extract (color)”, or (3) “color added”. The name of the coloring as in labeling examples (1) and (2) should reflect the name of the coloring as identified in 21 CFR 73 with the exception of “fruit juice” and “vegetable juice” which may be replaced by the specific identity of the coloring regulated by this category (e.g. “colored with fruit juice” or “colored with elderberry juice”; “colored with “vegetable juice” or “colored with red cabbage juice”). Although any of these labels can presently be used to label Carmine, regulations are pending before the FDA to limit labeling of this coloring to “colored with carmine” or “carmine (color)” to prevent consumers who may be allergic from unintentionally consuming it. If one of D.D. Williamson’s organic caramel colors is used, then customers can list “organic caramel color” on the ingredient statement. The language “Certified Organic by QAI” is required on the package label of a retail product so the consumer can see which agency accredited by the United States Department of Agriculture (USDA) is the organic certifier.

Please feel free to contact us with additional questions or concerns.

Jennifer Guild, Global Food Science and Regulatory Manager
Margaret Lawson, Vice President, D.D. Williamson
Campbell Barnum, Vice President, D.D. Williamson
Stephen Lauro, President, colorMaker