FD&C colors: an introduction

Colour additives are used across cosmetics, pharmaceuticals, food and personal care, and because these products are eaten, swallowed or worn on skin, the colourants in them are regulated more tightly than almost any other ingredient class. In the United States that regulation runs through the FD&C system: colour additives certified under the Federal Food, Drug, and Cosmetic Act as suitable for human use.

What are FD&C color additives?

FD&C colours are synthetic organic colourants that have passed FDA review and are permitted in listed applications. Historically many were derived from coal tar, which is why older texts use that term; today the feedstocks are largely petrochemical, and the "coal tar" label persists only as a legal legacy.

The system is unusual in requiring batch certification. It is not enough for a colour to be approved as a substance; each individual manufactured batch must be submitted to the FDA, tested against identity and purity specifications, and issued its own certification lot number. That lot number should follow the material through the supply chain.

FD&C, D&C and External D&C

The prefix is the most useful part of the name, because it states exactly where the colour may be used. This is the distinction most often missed.

• FD&C: permitted in food, drugs and cosmetics. The broadest scope, and the smallest list.
• D&C: permitted in drugs and cosmetics, but not in food.
• External D&C: permitted only in externally applied drugs and cosmetics. These may not be used on the lips or in the eye area.

Reading the prefix therefore answers a compliance question before you open the specification. It also explains a common error: D&C Red No. 33 is frequently written as "FD&C Red 33", but it is a D&C colour and is not permitted in food.

Where the lists live

US colour additive listings sit in Title 21 of the Code of Federal Regulations:

• 21 CFR Part 73: colour additives exempt from certification, mostly inorganic pigments and naturally derived colours such as iron oxides, titanium dioxide, mica and carmine.
• 21 CFR Part 74: colour additives subject to batch certification (the FD&C, D&C and External D&C colours).
• 21 CFR Part 82: listing of certified provisionally listed colours.

Each entry states the permitted uses and any restrictions or maximum levels, so an approval is always specific to an application rather than general.

Reading a colour name

Take FD&C Red No. 40. The prefix says food, drugs and cosmetics; the colour and number identify the specific molecule (Allura Red AC, CI 16035). Names sometimes appear abbreviated on labels ("Blue 1" for FD&C Blue No. 1), and cosmetic labels for international markets carry the CI number instead, which is the identifier regulators outside the US work from. See how to read a CI number.

Meaning of "lake"

A lake is a water-insoluble pigment made from a water-soluble dye. The dye is precipitated onto a substrate, usually alumina, to fix it as an insoluble particle. The name follows: FD&C Blue No. 1 Aluminum Lake.

The distinction is a practical one for formulators, not a technicality. A dye dissolves, giving transparent, saturated colour in water-based systems. A lake disperses, giving opaque colour that works in anhydrous and oil-based products (lipsticks, pressed powders, tablet coatings), where a soluble dye would bleed or fail to disperse. Lakes are also generally more stable to light and pH.

The FD&C colours are widely used in cosmetics because they deliver bright, reproducible shades with documented identity and a certification lot number behind every batch. For the range of VINCOL shades with CI numbers, see the benefits of using FD&C colours.