From Shampoo to Cereal: Seeing to the Safety of Color Additives

by Food and Drug Administration (FDA)

Color Additives Fact Sheet

Color additives have long been a part of human culture. Archaeologists date cosmetic colors as far back as 5000 B.C.

FDA separates color additives into two categories. These are colors that the agency certifies (derived primarily from petroleum and known as coal-tar dyes) and colors that are exempted from certification (obtained largely from mineral, plant, or animal sources). Only approved substances may be used to color foods, drugs, cosmetics, and medical devices.

FDA requires domestic and foreign manufacturers of certain colors to submit samples from each batch of color produced. FDA scientists test each sample of these colors to confirm that each batch of the color is within established specifications. These certified colors are listed on labels as FD&C, D&C or external D&C. Using the uncertified versions of color additives that require certification is illegal in foods, drugs, cosmetics, and medical devices.

The color certification program is self-supporting because the law requires manufacturers to pay FDA a user fee for each pound of color the agency certifies. In Fiscal Year 2000 FDA certified more than 13 million pounds of color additives.

It starts when you get up in the morning.

You snatch a bar of soap and scrub your face. That's likely your first dab into the palette of added tints and hues that will color much of your day. Most of us hardly notice them, but color additives surround us. They're in shampoos. In shaving cream. Toothpaste. Deodorant. Contact Lenses. Lipstick, eyeliner, and mascara. At breakfast, the colors keep coming. Juice, cereal, pastry, coffee creamer, vitamins — all are likely to have added colors.

Color additives make things attractive, appealing, appetizing. They also serve as a code of sorts, allowing us to identify products on sight, like medicine dosages and candy flavors. We might reason, for example, that a pale green candy is mint flavored, while a darker green one is lime. Based on our color analysis alone, there will probably be no surprises when we pop the candy into our mouths.

With this rainbow hodgepodge bombarding us daily, it's only natural that consumers might wonder: Just how safe are all these colors? "Very," says John E. Bailey, Ph.D., acting director of FDA's Office of Cosmetics and Colors.

He explains that FDA has, over nearly a century, refined its process of monitoring and controlling color additive use. By law, industry must prove the safety of colors it sells. FDA ensures that colors on the market are safe for their intended purposes and do not cover up product inferiority or otherwise deceive consumers. FDA watches domestic color use closely, seizing products found unsafe.

Still, Bailey says, some consumers believe color additives can cause health problems or even be hazardous. This notion stems, he says, from persistent public attitudes about colors banned in the past. He says consumer confidence in the safety of all colors can be shaken when FDA removes a color from the market. But he emphasizes: "I think we can say with assurance that today's colors are safe if used properly and that consumers need not be worried."

Yellow Means Caution

Two categories make up FDA's list of permitted colors: those the agency certifies by batch (derived primarily from petroleum and coal sources) and ones exempt from batch certification (obtained largely from plant, animal, or mineral sources — fruit juice, carmine, and titanium dioxide, for example). Colors found to be potentially hazardous have been purged from the list of permissible additives. What remains is a wide color spectrum approved for use in foods, over-the-counter and prescription drugs, cosmetics, or in medical devices such as surgical sutures and contact lenses.

Though these colors have a good safety record, one commonly used additive reportedly has prompted minor adverse reactions in some people. It is FD&C Yellow No. 5, listed as tartrazine on medicine labels, a color found widely in beverages, desserts, processed vegetables, drugs, makeup, and many other products. FDA certifies more than 2 million pounds of it yearly.

In 1986, an FDA advisory committee concluded that Yellow No. 5 may cause itching or hives in a small population sub-group. This kind of skin reaction usually is not a serious one, says Linda Tollefson, D.V.M., an FDA epidemiologist "Reactions are classified as hypersensitive and are not true allergic reactions, which would be more severe."

Nonetheless, since 1980 (for drugs) and 1981 (for foods), FDA has required all products containing Yellow No. 5 to list the color on their labels so consumers sensitive to the dye can avoid it. (As of May 8, 1993, labels must list all certified colors as part of the requirements of the Nutrition Labeling and Education Act of 1990.)

A Certified Success

FDA requires domestic and foreign certifiable color manufacturers to submit samples taken from every batch of color produced. The agency has listed each certifiable color based on a specific chemical formula shown to produce no harmful effects in laboratory animals.

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.