Red No. 3 and Other Colorful Controversies

by Food and Drug Administration (FDA)

The lure of red cherries in canned fruit cocktail is legendary in many American families. Siblings fight over them, parents use them to bribe or treat their children, and even adults count the cherries spooned into their dessert. But, the days of the fruit cocktail cherry colored by FD&C Red No. 3 may be numbered. Because large amounts of the color have been shown to cause cancer in rats, FDA recently ended certain uses of FD&C Red No. 3 and plans to end the remaining uses. The cherries in 21st century fruit cocktail could well be light brown.

Color has long been recognized as important in consumer acceptance of nearly every food, medication and cosmetic product. Even the hue of the containers can make the difference between a best seller and a "no-sale-er."

A research project in the 1970s, reported in the October 1973 issue of Marketing, illustrated just how big the impact of color can be on the acceptance of food items in particular. Research volunteers were served a meal of steak, peas and French fries. They ate part of the meal under special lighting that concealed the fact that the colors of the food had been altered. When, under normal lighting, the test group discovered that their steaks were blue, peas red, and french fries green, some participants became ill at the sight of the unnaturally colored food they had been eating.

Color Safety

Food once was colored only with natural dyes. Beets, peppers, grape skins, saffron, and even brilliantly scarlet extracts prepared from dried bodies of cochineal insects lent their distinctive colors to the cook's creativity.

By the 19th century, colors derived from other chemicals came into use — with sometimes serious health consequences (see "Additives for Eye Appeal" in the July-August 1973 issue of FDA Consumer). Lead chromate and copper sulfate began to be used to tint candy and pickles. Arsenic and other poisonous impurities were added when mixing up new color additives. Dyes made from coal-tar and petroleum derivatives also appeared in foods, drugs and cosmetics.

How, then, can a consumer be sure that the bright primary colors and the subtle shadings that color many consumer products today are safe to eat, use in drugs, put on skin or hair, or — as with colored contact lenses — stick in the eyes? A monitoring process — directed by FDA and refined over several decades — ensures that this is so.

FDA began a comprehensive assessment of the safety of color additives with the passage of the Pure Food and Drugs Act of 1906. The country had changed from an agricultural to an industrial nation. No longer did most Americans live on farms and produce their own food. Instead, much of the food a nation of city dwellers ate was processed, chemically preserved, and marketed by large firms competing for consumers' attention.

It was a time of triumph for synthetic dyes, followed by concern on the part of public health officials about the safety of these dyes. Harvey Wiley, chief of USDA's Bureau of Chemistry, challenged the ease with which manufacturers added chemicals to food. Food safety became Wiley's special cause, and he was instrumental in bringing about passage of the first federal Food and Drugs Act in 1906.

This landmark food law prohibited the use of any color additive in foods if the color would deceive the consumer, conceal inferiority or damage, or otherwise result in misbranding and adulteration. However, Wiley believed that the use of color additives in food required further investigation. He hired an outside consultant, dye expert Bernard Hesse, Ph.D., to study the problem.

After reviewing 80 of the most commonly used colors, many of which had never been tested before, Hesse recommended only seven color additives as safe for use in food. His recommendation was announced in a 1907 regulation, Food Inspection Decision 76, which also introduced a system for voluntary certification of synthetic food colors.

Pre-Market Approval

The Federal Food, Drug, and Cosmetic Act of 1938 elaborated on the earlier regulations by providing for the listing and mandatory certification of synthetic color additives used in foods, drugs and cosmetics. During the 1950s, a safety concern associated with the improper use of FD&C Orange No. 1 prompted additional safety studies on color additives used in food, including FD&C Red No. 3.

Then, in 1960, Congress amended the Food, Drug, and Cosmetic Act of 1938 to set up a pre-market approval system for new color additives and to require demonstration of the safety of color additives already in use.

Approved color additives were divided into two groups: those requiring FDA's certification (synthetic dyes made mostly from coal tar and petroleum derivatives) and those exempt from FDA's certification (substances derived from vegetable, animal or mineral products). Each batch of a synthetic color is tested by the manufacturer and a sample submitted to FDA for certification according to specifications in the Code of Federal Regulations. Colors exempt from batch certification must also meet specifications in the CFR.

The 1960 amendments placed the color additives already in use on a provisional list to permit their continued use while the manufacturers developed the necessary data for a petition to support the listing of the color additive.

Many of the color additives requiring certification come in two forms: straight colors and lakes. Straight colors in many cases are water-soluble dyes. Certain straight colors are used to make "lakes" or water-insoluble forms of the color additive. Lakes are used in products in which leaching or "bleeding" of color would pose problems, such as in cookie fillings, coated tablets, candies, chewing gum, and lipsticks. The agency is currently planning a proposal regarding the regulation of lakes.

Manufacturers seeking approval for new color additives or for those on the provisional list were required to submit a petition to FDA with scientific data demonstrating that a specific color was safe for its intended uses. If the agency approved the petition, the color was placed on a "permanent" listing. Colors can be approved for use in food, drugs, and cosmetics (FD&C), in drugs and cosmetics only (D&C), or specifically for external drug and cosmetic use (Ext. D&C).

To date, 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.

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.