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FDA Bans Cosmetic, Some Other Uses Of Red Dye No. 3

January 29, 1990 GMT

WASHINGTON (AP) _ The government banned some uses of the color additive Red No. 3 on Monday. As a result, ″red″ may not be as ″red″ in lipstick, cake frostings, cough drops and some processed fruits and juices.

The Food and Drug Administration announcement said some uses of the dye are being halted because Red No. 3 in high doses has been shown to cause cancer in rats.

The cancer risk is considered so small that the FDA said that existing products that contain the color may be used. The ban on Red No. 3 will apply only to new manufacturing, the FDA said.


The FDA action prevents the use of the red dye in products where the color is mixed chemically with another additive.

Direct addition of the dye to a product will continue, but the FDA also announced its intention to halt this use eventually.

Under the new rules, FDA spokesman Emil Corwin said Red No. 3 can no longer be used in any cosmetic product, including lipsticks, powders, blushes, shampoos, skin care lotions or bath oils.

It also is excluded from use in cake frostings, cough drops, herbs and spices, flavorings, some processed fruits and juices, chewing gum, cake mixes and dietary foods. Even the wax on cheeses can no longer contain the red dye, said Corwin.

Red No. 3 is one of seven primary colors approved for food, drug and cosmetic use, but it holds a very important position because it is the ″closest to primary red,″ says John Hallagan of the Certified Color Manufacturers Association.

″There will be a number of products that won’t be red any more,″ said Hallagan.

The six other colors are Red No. 40, Blue Nos. 1 and 2, Green No. 3, and Yellow Nos. 5 and 6.

″Because it was closest to the primary color of red, No. 3 is ideal for blending,″ said Hallagan. Mixing No. 3 with other primary colors could make a whole variety of shades based on red, ranging from orange to maroon.

Without No. 3, he said, ″the pallet of colors will be reduced significantly. The variability will be reduced.″

Red No. 40, he said, is a different shade of red and is not as stable.

Hallagan said that about 300,000 pounds of Red No. 3 is manufactured annually in the United States.

Irene Malbin of the Cosmetic Toiletry and Fragrance Association said that a 1989 survey of cosmetic manufacturers showed that red No. 3 ″was not used in very many cosmetic products″ because of uncertainty over its status.

As a result, dropping red No. 3 from cosmetic use will not have a serious effect on the colors available to customers, said Ms. Malbin.

But association president Ed Kavanaugh attacked the FDA action as being ″arbitrary and capricious″ because the agency permitted Red No. 3 to continue to be used in food ″and other ingested products.″

Under the FDA order, Red No. 3 still can be applied directly to some products until further agency action is taken.

That means it still can be applied directly to meat, pet food, nut products, fruit and fruit juices, candy and confections, breakfast cereals and ingested drugs.

Corwin said the cherries in fruit cocktail, for example, can continue to be tinted red by the color additive.

In announcing the FDA action, Dr. Louis Sullivan, secretary of the Department of Health and Human Services, said: ″The actual risk posed by red No. 3 is extremely small. However, federal law in this area is clear. There have been laboratory studies which showed that very high doses of Red No. 3, administered directly in the diet, caused cancer in rats.″

Sullivan said that Congress should consider updating the statutes ″to reflect advances in the methods of scientific assessment that were not available when the law was originally passed in 1960.″

An FDA statement said the risk of getting cancer from Red No. 3 is no larger than 1 in 100,000 over a lifetime of consumption. This compares to a natural disaster risk of about 70 in 100,000, and a risk from death in railroad or air crashes of about 6 in 100,000, the agency said.