FDA Compliance Policy Guide – Label Declaration

U.S. Food and Drug Administration (FDA)
Compliance Policy Guide 7127.01
Chapter 27 — Color

Subject: Label Declaration of Artificial Color

Background:

Section 403(k) of the FD&C Act states that if a food contains an artificial color is should bear labeling “stating that fact”.

Section 403(i)(2) of the FD&C Act permits a color to be listed on a food label as such without naming specifically the color used.

21 CFR 74.7705(d)(2) states that all foods, including butter, cheese, and ice cream containing FD&C Yellow # 5 shall specifically declare the presence of this color additive in the list of ingredients.

Questions have arisen concerning the use of terms “Food Color Added”, “artificial color”, and “natural color” on a label to indicate the presence of artificial color.

POLICY:

The use of the words “Food Color Added” may be erroneously interpreted to mean the color is derived from food. It also fails to state the artificiality of colors as required by section 403(k). Therefore, this terminology may not be
used.

For the purpose of label declaration in accordance with Section 403(k) of the Act, the terms “Artificially Colored”, “Artificial Color Added”, or an equally informative statement should be used which clearly indicates the addition of a color to a food and the fact that it is artificial, except where regulations require specific declaration of the color by common or usual name. FDA will not insist upon the use of the word “artificial” with the declaration of color as an ingredient, provided the declaration identifies the color by specific common or usual name and by function. Thus, terms such as “colored with _____” or “_____(color)” the blank being filled with the specific color name such as annatto, beet powder, beta carotene, etc.) is considered satisfactory.

The use of the words “natural color” or similar words containing the term “natural” may be erroneously interpreted to mean the color is a naturally occurring constituent in the food. Since all added colors result in an artificially colored food, we would object to the declaration of any added color as “natural”.

Initially published: Sept. 23, 1976 Revised: Aug. 1, 1985 Issuing Office: Office of Enforcement, Division of Compliance Policy Authority: Associate Commissioner for Regulatory Affairs