Color Additives

February 1990

Food once was colored only with natural dyes. Beets, peppers, grape skins, saffron, and even the brilliantly scarlet cochineal insects lent their distinctive colors to the cook's creativity. But, by the 19th century, colors derived from minerals came into use‏with sometimes serious health problems. Lead chromate and copper sulfate began to be used to tint candy and pickles. Arsenic and other poisonous impurities were added when mixing new color additives. Dyes and pigments made from coal tar and petroleum derivatives also appeared in the manufacture of foods, drugs and cosmetics.

So, how can you know that the bright primary colors and the subtle shadings that color nearly all consumer products today are safe to eat, put on your skin or hair, or stick in your eyes (contact lenses can be colored, too)? A monitoring process‏directed by FDA and refined over several decades‏ensures that this is so.

FDA began assessing the safety of color additives with the passage of the Pure Food and Drugs Act of 1906. But it was not until 1960 that Congress amended the Food, Drug, and Cosmetic Act of 1938 to set up a pre-market approval system for color additives and to reevaluate the safety of color additives already in use. FDA began a review of some 200 colors used in foods, drugs and cosmetics to determine whether they were safe for their intended use.

The 1960 amendments placed these color additives already in use on a provisional list to permit continued use while safety studies were conducted. The provisional list included color additives derived from petroleum and coal sources, as well as those derived from plants, animals and minerals. Manufacturers could submit a petition with scientific data demonstrating that a specific color was safe for commercial uses. If FDA agreed that the industry research established the color was safe, that color received approval in the form of a so-called "permanent" listing.

Initially, the provisional list was to be in effect for 30 months. But when necessary research studies could not be done so quickly, Congress authorized postponing the closing dates when warranted. Of the original 200 provisionally listed color additives, 90 have been listed as safe and the rest have either been withdrawn by industry or delisted by FDA.

Color additives come in two forms: straight colors and lakes. Straight colors in many cases are water-soluble dyes. Lakes are generally insoluble in water, and are used in products where leaching or "bleeding" of color would pose problems, such as in cookie fillings, coated tablets, candies, and chewing gum.

The last provisionally listed straight color additive was FD&C Red. No. 3. Red No. 3 imparts a watermelon-red color, and its straight form was provisionally listed for use in cosmetics and in externally applied drugs. In addition, the lake form of Red No. 3 was provisionally listed for use in food, cosmetics and drugs, both internal and external. Also, in response to a petition by the Certified Color Manufacturers Association (CCMA) in 1969, Red No. 3 was permanently listed for use in ingested drugs and in foods, including certain baked goods, cherries, dairy products, dessert powders, dietary supplements, seasonings, jellies, jams, and vegetable products.

However, studies completed in the 1980s showed that very high doses of FD&C Red No. 3 caused thyroid tumors in male rats. The Cosmetic, Toiletry and Fragrance Association and CCMA argued that there was no direct carcinogenic effect shown at the low levels in use. But FDA decided that the evidence of thyroid tumors in rats was clear, and that the additional research cited by industry did not prove that an indirect mechanism‏such as hormonal effect triggered by the dye‏caused the tumors in the rats. FDA therefore rejected the manufacturers' petition for permanent listing of the color.

Accordingly, on Jan. 29, 1990, the agency ended the provisionally listed uses of Red No. 3. The action prevents further use of the color additive in about one-fifth of its uses‏in cosmetics such as lipsticks, in externally applied drugs, and in the "lake" pigment form in food, drugs and cosmetics.

The decision to ban the uses of Red No. 3 is based on the legal mandate of the Delaney Clause of the 1960 Color Additive amendments. Under that clause, products shown to have a carcinogenic effect in laboratory tests, no matter how small, cannot be approved for use by FDA.

The risk of Red No. 3 is estimated to be no larger than 1 in 100,000 over a lifetime of consumption. This estimate errs on the side of safety, and the risk may actually be smaller. The conservative risk estimate procedures have been established to overwhelmingly ensure that carcinogens are not added to the food supply.

The overall risk from natural disasters (such as earthquakes and hurricanes) is close to 7 in 10,000 per lifetime. For manmade disasters (such as railroad accidents and major air crashes), the risk is close to 6 in 100,000. Although these "actual" risks are not directly comparable to those for Red No. 3‏the risks from the color are worst case estimates from animal data‏the comparison helps put the risk in perspective.

The ban of the provisionally listed uses applies to new manufacturing and production of affected products. Because any health risks posed by Red No. 3 are extremely small, FDA concluded consumers may continue to use existing supplies of products that already contain that color.

Uses of the straight form of Red No. 3 in foods and ingested drugs remain permanently listed. These uses are not affected by FDA's ban of the provisionally listed uses. However, following the mandate of the Delaney Clause, the agency will next consider these uses as well. Banning an already permanently listed dye will require a separate, more complex action than terminating the provisional uses. The rule-making procedure that FDA must follow to remove the permanently listed uses requires time for public comment and will take several years. Again, this continued use is consistent with the very low public health risk involved.