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U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics Fact Sheet
February 7, 1995

COLOR ADDITIVES

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.

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 1994 FDA certified almost 12 million pounds of color additives.

U. S. Food and Drug Administration
FDA Consumer
December 1993

FROM SHAMPOO TO CEREAL
SEEING TO THE SAFETY OF COLOR ADDITIVES

by John Henkel

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.

Each color has chemical "specifications" that place restrictions on the levels of impurities allowed in the additive. In some cases, these limitations are designed to ensure that the color contains no cancer-causing substances. Using chromatography and other sophisticated analytical techniques, FDA scientists probe sample compositions to confirm that each batch is within these limitations.

"We analyze every batch because every batch is a little different from the one before it," says Bailey. He explains that complex organic chemical reactions occurring during manufacturing can throw off a sample's composition. It's like baking a cake: Even though you follow a recipe closely, the cake turns out just a little different each time.

With certifiable colors, a shift in composition can mean rejection of an entire batch. In fiscal year 1992, of 3,943 batches tested, the agency rejected 40. FDA also regularly inspects color manufacturers and end users such as candy makers.

FDA is especially vigilant in monitoring products from foreign countries, which may contain color additives that are illegal domestically. The agency regularly seizes entire product shipments that contain prohibited colors. Often, this detective work comes easily. FDA, through its "import alerts," flags certain products. "You look for a pattern," says Bailey.

The batch certification program supports itself because the law requires manufacturers to pay FDA a user fee for every pound of color the agency certifies. "We like to think of batch certification as a government success story," Bailey says.

THE RED SCARE

In 1960, amendments to the Food, Drug, and Cosmetic Act of 1938 added the so-called Delaney anti-cancer clause to FDA's legal mandate. Among other things, the clause prohibits marketing any color additive the agency has found to cause cancer in animals or humans, regardless of amount.

In recent years, regulators have faced a dilemma in light of technological advances that enable scientists to identify smaller and smaller concentrations of a substance and conduct more sensitive toxicological tests. Are such tiny amounts a health threat? Scientists have yet to answer this question. Congress has held hearings to examine the pros and cons of liberalizing the Delaney clause. At press time, debates on the issue were in progress.

FDA applied the Delaney clause in 1990 when it outlawed several uses of the strawberry-toned FD&C Red No. 3. The banned uses include cosmetics and externally applied drugs, as well as uses of the color's non-water-soluble "lake." FDA previously had allowed these "provisional" uses while studies were in progress to evaluate the color's safety. Research later showed large amounts of the color causes thyroid tumors in male rats.

Though FDA viewed Red No. 3 cancer risks as small--about 1 in 100,000 over a 70-year lifetime--the agency banned provisional listings because of Delaney directives. At the same time, Red No. 3 has "permanent" listings for food and drug uses that are still allowed although the agency has announced plans to propose revoking these uses as well. For now, Red No. 3 can be used in foods and oral medications. Products such as maraschino cherries, bubble gum, baked goods, and all sorts of snack foods and candy may contain Red No. 3.

According to the International Association of Color Manufacturers, Red No. 3 is widely used in industry and hard to replace. It makes a very close match for primary red, which is important in creating color blends. It doesn't bleed, so drug companies use it to color pills with discernible shades for identification.

If Red No. 3 joins the ranks of colors forbidden for all uses, it won't be the first FD&C Red in recent years to be pulled from the market. FDA banned FD&C Red No. 2, a tint that continues to be an enigma, in 1976.

In the early 1970s, data from Russian studies raised questions about Red No. 2's safety. Several subsequent studies showed no hazards. FDA conducted its own tests, which were inconclusive. The consumer-oriented Health Research Group petitioned FDA to ban the color, while congressional and public interest mounted.

FDA turned the matter over to its Toxicology Advisory Committee, which evaluated numerous reports and decided there was no evidence of a hazard. The committee then asked FDA to conduct follow-up analyses. Agency scientists evaluated biological data and concluded that "it appears that feeding FD&C Red No. 2 at a high dosage results in a statistically significant increase" in malignant tumors in female rats.

There still was no positive proof of either potential danger or safety. FDA ultimately decided to ban the color because it had not been shown to be safe. The agency based its decision in part on the presumption that the color might cause cancer.

The judgment had a profound effect on consumer attitudes toward certifiable colors, says FDA's John E. Bailey. "The Red No. 2 decision will always be with us, he says. For example, some candy manufacturers reacted by removing red-colored pieces from their products, even if there was no Red No. 2 present. They were afraid sales would plummet because of public perception that red candies were dangerous.

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.

For a complete list of all colors approved for use in foods, drugs, cosmetics, and medical devices contact:

Office of Cosmetics and Colors (HFS-125)
Food and Drug Administration
200 C Street, S.W.
Washington, DC 20204
(202) 205-4494

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. Consumers can register complaints two ways - by contacting their FDA district office (see local phone directory) or by sending written reports of adverse reactions to:

ARMS
HFS-636
Food and Drug Administration
200 C St., N.W.
Washington, DC 20204

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.

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.

- J.H.

John Henkel is a staff writer for FDA Consumer.

U.S. Food and Drug Administration
FDA CONSUMER, December 1993