FDA Standards for Coloring Certification and Nomenclature in America

Categories of Color Additives for Use in the American Market

Color additives regulated by the Food and Drug Administration (FDA) are divided into two main categories:

1. Color Additives Exempt from Certification – Do not require batch certification and include compounds like beta-carotene and iron oxides.
2. FDA Certified Color Additives – Subject to batch certification, with names like FD&C Red No. 3 or D&C Orange No. 5.

Nomenclature System for FDA Certified Color Additives

The naming of FDA certified color additives consists of three distinct elements:

• Predominant Color Shade (e.g., Red, Yellow, Blue, Violet)
• Sequential Number of the Color (e.g., Red No. 40 indicates the fortieth certified red color)
• Usage Code (e.g., FD&C, D&C, Ext. D&C)

Interpretation of FDA Usage Code

Once certified, the FDA assigned usage codes to colors indicating the categories of products in which the color could be used:

• FD&C – Authorized for use in foods, drugs, and cosmetics.
• Citrus – Used specifically for citrus fruits (e.g., Citrus Red No. 2).
• D&C – Approved for use in drugs and cosmetics.
• Ext. D&C – Intended exclusively for external drugs and cosmetics.

However, due to FDA regulatory changes over time, these usage codes are now obsolete. For example:

• D&C Black No. 2 – Despite the presence of the letter "D" (Drug), is not authorized for use in pharmaceutical products.
• FD&C Blue No. 2 – Although including the letter "C" (Cosmetic), is not approved for cosmetic use, but solely for food, ingestible drugs, and surgical sutures.

Simplification in the Naming of Color Additives Used in America 

The FDA sometimes allows the use of just the shade and number to identify a certified color (e.g., Red 40 instead of FD&C Red No. 40). However, in other contexts, the agency still requires the use of the full usage code, for historical regulatory reasons.