Cosmetic Colorants: Beauty & the FDA

There is so much chemistry, legislation, and biology related to color additives in cosmetics that it can be very difficult to understand. The complexity of color additives issues also makes it difficult for the ordinary consumer to know that their cosmetics are really safe. Knock-off cosmetics not made in the USA do not generally abide by FDA regulations.

First, know that color additives in cosmetics include dyes and pigments. This group of ingredients is the most tightly regulated group in the cosmetic industry today. All color additives for cosmetics must be specifically pre-approved for use by the Food and Drug Administration. The Federal Food, Drug, and Cosmetic Act governs cosmetics and requires that the FDA issue a specific regulation for each color additive that prescribes its conditions of use and the specifications for its safe use, i.e. the color may be approved for use on cheeks, but not on lips.

A little cosmetic history: Going back to 4000 BC, Egyptian women applied galena mesdemet (from copper and lead), malachite (from copper), and other naturally occurring colors (e.g. paprika) to their faces, often signifying their class. Moving through history, ingredients like henna dyes or rice powders have been seen in many cultures, including China, Japan, India, and North Africa. By the 1500s, European women often lightened their skin with a variety of colored products, including white lead paint. Queen Elizabeth I of England was a well-known white lead user, which may have also been a product that led to her death. By the 1800s, zinc oxide began to replace some of the deadly lead and copper white mixtures that had killed many women in previous years. In 1856, the first synthetic dye, mauve, was discovered and similar dye discoveries quickly followed. Due to the fact that these dyes were initially produced from byproducts of coal processing, they were labeled "coal-tar dyes". By the 1900s, many artificially colored cosmetics became available and quickly began to grow in popularity.

After a number of cases of consumers getting sick from their cosmetic products, the ingredients were assessed to find that many synthetic colors contained a variety of poisonous chemicals, for example, lead, arsenic, and mercury. The Federal Food, Drug, and Cosmetic Act of 1938 was passed to regulate specifically cosmetics. By the 1960s, new amendments came about to prohibit the use of color additives demonstrated to be a carcinogen.

Today, color additives are very tightly regulated due to the historical risks of these ingredients. There is currently a long list of color additives that aren't allowed in cosmetic products. Due to demonstrated risks of contamination with heavy metals, once naturally derived ingredients, for example, Iron Oxides, have to be now made in a lab to ensure consumer safety. As a result, aside from botanicals, which generally aren't used in make-up due to their drawbacks (e.g. poor mixing and staining abilities plus possibilities of skin irritation or smell), store-bought "all-natural" makeup doesn't really exist anymore.

The official names for other color additives in the U.S. are also designated by the FDA. Colors subject to batch certification are designated as FD&C (food, drug, and cosmetics), D&C (drug and cosmetics), or Ext. D&C (external drugs and cosmetics). This is followed by a color designation, such as blue or red, and by No. (for number), and by a numeral. An example of such a name is FD&C Red No. 40. Colors made by combining these "straight" colors with "substrates" (sodium, potassium, aluminum, barium, calcium strontium, or zirconium) are known as "lakes" and are named using the same convention, but with the addition of the word lake and the substrate, for example, FD&C Red No. 40 Aluminum Lake.

Natural botanical colors approved by the FDA include:

Annatto is a yellow-to-orange colorant derived from the evergreen shrub Bixa Orellana.

Carmine is a chemical lake that has a unique blue shade of red and stands apart from other natural colorants, which tend to be duller. It is derived from the extract of dried female cochineal beetles found in Peru. It takes approximately 155,000 beetles to make one kilogram of carmine. Carmine is not considered when products claim no animal-derived ingredients or are cruelty-free due to their insect origins.

Henna is a dye extracted from the henna plant. It is used to color hair and a temporary dye on the skin. Its use in the US is limited to hair applications and is specifically prohibited from use on eyelashes or brows because of the concern for eye irritation.

Beta-Carotene is a yellow to orange pigment that is obtained from the fungus Blakeslea trispora.

Caramel is a brown colorant made by burning of sugar.

Guaiazulene is a derivative of azulene, a component of chamomile. It is a blue colorant that is approved for external use only in the US. At a cost of over $200 per kilogram, it has very limited use.

Guanine is a natural pearl pigment made from the scales of herring, sturgeon, or salmon fish.