Color Additives Safety, Part 4

by Food and Drug Administration (FDA)

(Page 4 of 4)

In the late 1800s, some manufacturers colored products with potentially poisonous mineral- and metal-based compounds. Toxic chemicals tinted certain candies and pickles, while other color additives contained arsenic or similar poisons. Historical records show that injuries, even deaths, resulted from tainted colorants. Food producers also deceived customers by employing color additives to mask poor product quality or spoiled stock.

By the turn of the century, unmonitored color additives had spread through the marketplace in all sorts of popular foods, including ketchup, mustard, jellies, and wine. Sellers at the time offered more than 80 artificial coloring agents, some intended for dyeing textiles, not foods. Many color additives had never been tested for toxicity or other adverse effects.

As the 1900s began, the bulk of chemically synthesized colors were derived from aniline, a petroleum product that in pure form is toxic. Originally, these were dubbed "coal-tar" colors because the starting materials were obtained from bituminous coal. (These formulations still are used today — albeit safely — for most certifiable color additives.)

Though colors from plant, animal and mineral sources — at one time the only coloring agents available — remained in use early in this century, manufacturers had strong economic incentives to phase them out. Chemically synthesized colors simply were easier to produce, less expensive, and superior in coloring properties. Only tiny amounts were needed. They blended nicely and didn't impart unwanted flavors to foods. But as their use grew, so did safety concerns.

In 1906, Congress passed the Pure Food and Drugs Act. This marked the first of several laws allowing the federal government to scrutinize and control additives use. The act covered only food coloring. It was not until passage of the Federal Food, Drug, and Cosmetic Act of 1938 that FDA's mandate included the full range of color designations consumers still can read on product packages: "FD&C" (permitted in food, drugs and cosmetic); "D&C" (for use in drugs and cosmetics) and "Ext. D&C" (colors for external-use drug and cosmetics).

Public hearings and regulations following the 1938 law gave colors the numbers that separate their hues. These letter and number combinations — FD&C Blue No. 1 or D&C Red No. 17, for example — make it easy to distinguish colors used in food, drugs or cosmetics from dyes made for textiles and other uses. Only FDA certified color additives can carry these special designations.

The law also created a listing of color "lakes." These water-insoluble forms of certain approved colors are used in coated tablets, cookie fillings, candies, and other products in which color bleeding could make a mess or otherwise cause problems.

Though the 1938 law did much to bring color use under strict control, nagging questions lingered about tolerance levels for color additives. One incident in the 1950s, in which scores of children contracted diarrhea from Halloween candy and popcorn colored with large amounts of FD&C Orange No. 1, led FDA to retest food colors. As a result, in 1960, the 1938 law was amended to broaden FDA's scope and allow the agency to set limits on how much color could be safely added to products.

FDA also instituted a pre-marketing approval process, which requires color producers to ensure, before marketing, that products are safe and properly labeled. Should safety questions arise later, colors can be reexamined. The 1960 measures put color additives already on the market into a "provisional" listing. This allowed continued use of the colors pending FDA's conclusions on safety.

From the original 1960 catalog of about 200 provisionally listed colors, which included straight colors and lakes, only lakes of some colors remain on the provisional list. Industry withdrew or FDA banned many, while the rest became permanently listed and are still used. Some of these colors, derived from coal or petroleum sources, are subject to certification and carry the F,D, or C prefix. Others, exempt from certification, are pigments and colors derived from plant, animal and mineral sources. They are found in a myriad of products — from the caramel that tints cola drinks to the orange annatto that gives color to cheese.

FDA certified over 11.5 million pounds of color additives last fiscal year. Of all those colors straight dye FD&C Red No. 40 is by far the most popular. Manufacturers use this orange-red color in all sorts of gelatins, beverages, dairy products and condiments. FDA certified more than 3 million pounds of the dye in fiscal year 1992 — almost a million pounds more than the runner-up, FD&C Yellow No. 5.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.