Color Additives Safety, Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

Though long gone from U.S. shelves, products tinted with Red No. 2 still can be found in Canada and Europe. Whether the color is gone forever in the United States remains to be seen. FDA and industry officials say it could stage a comeback. Industry could petition FDA to list Red No. 2 as a certifiable color if animal study data adequately show safety. If FDA then agrees, consumers could once again be munching on candies and using other products tinted with the deep-red dye.

Animal-Less Studies?

Because of the cost, it is unlikely that industry will commission new animal studies to measure Red No. 2's safety. But advances in toxicological trial methods could enable scientists to assess potential hazards without using animals. Technology is moving toward a time when chemical substances could be evaluated accurately with a battery of short-term tests conducted in the test tube. Such analyses would greatly shorten the time and expense of evaluating not only colors but other food additives and environmental chemicals.

These test tube trials are not here yet. But if and when they arrive, they may have government and industry taking another look at certain color additives, including Red No. 2.

As for the colors that remain in use, consumers can rest assured that color additives are among the most scrutinized of all food ingredients. Next time you quaff a glass of red fruit punch or pop a blue pill, consider that those colors have been studied, studied, and restudied, sometimes dozens of times. And remember that FDA inspects every batch of certifiable colors used in consumer products.

You may, however, want to avoid consuming huge quantities of any one color additive. As Bailey says: "Good sense is the best policy. As with many other food ingredients, don't overuse any one product. Practice everything in moderation."

Color Additive Terms

Allura Red AC - the common name for uncertified FD&C Red No. 40

Certifiable color additives - colors manufactured from petroleum and coal sources listed in the Code of Federal Regulations for use in foods, drugs, cosmetics, and medical devices

Coal-tar dyes - coloring agents originally derived from coal sources

D&C - a prefix designating that a certifiable color has been approved for use in drugs and cosmetics

Erythrosine - the common name of FD&C Red No. 3

Exempt color additives - colors derived primarily from plant, animal and mineral (other than coal and petroleum) sources that are exempt from FDA certification

Ext. D&C - a prefix designating that a certifiable color may be used only in externally applied drugs and cosmetics

FD&C - a prefix designating that a certified color can be used in foods, drugs or cosmetics

Indigotine - the common name for uncertified FD&C Blue No. 2

Lakes - water-insoluble forms of certifiable colors that are more stable than straight dyes and ideal for product in which leaching of the color is undesirable (coated tablets and hard candies, for example)

Permanent listing - a list of allowable colors determined by tests to be safe for human consumption under regulatory provisions

Provisional listing - a list of colors, originally numbering about 200, that FDA allows to continue to be used pending acceptable safety data.

Straight dye - certifiable colors that dissolve in water and are manufactured as powders, granules, liquids, or other special forms (used in beverages, baked goods, and confections, for example)

Tartrazine - a common name for uncertified FD&C Yellow No. 5.

Adverse Reactions?

Though reactions to color additives are rare, FDA wants to know about them. The agency operates the Adverse Reaction Monitoring System (ARMS) to collect and act on complaints concerning all food ingredients, including color additives.

A Colorful History

Color additives have long been a part of human culture. Archaeologists date cosmetic colors as far back as 5000 B.C. Ancient Egyptian writings tell of drug colorants, and historians say food colors likely emerged around 1500 B.C.

Through the years, color additives typically came from substances found in nature, such as turmeric, paprika and saffron. But as the 20th century approached, new kinds of colors appeared that offered marketers wider coloring possibilities. These colors, many whipped up in the chemist's lab, also created a range of safety problems.

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.